CTMS User Manual For Clinical Trial Research Management
Contents
1. My Participants ponsor Protocol Number 21 22 23 Help User Guide Status Trial Registration Number 28 29 30 Approval Status External Monitor 2011 Classification Category Show Master Trials Only O 1 Day W 1hr My Action Items My Messages e If you do not know the exact spelling of the Pl s name you can instead look the name up e Click the Set button to the right of PI field This will pop open a new window where you can find the PI by their last name e Click on the first letter of the Pl s last name such as D for Delucchi Browse Alpha Split Windows Internet Explorer Choose principal investigator k LM NO PORS TUVWKRYV 2 Daisak Barbara Delucchi Loredana Filter by Position Local intranet 100 e Select the investigator name from the Investigator drop down menu e Click the Save button Research IT Page 6 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center e Click the Open Locate button The search results will display all the studies where the person selected is the PI e Scroll through the search results to locate the desired study to open NYU SoM InfoEd Test Portal Show List Search For Report On My Participants Help User Guide Logged in User mr infoed pii Find Funding CV Database Clinical Trials Search For Use for wildcar2. E 5 O t ea w s nuna 4 g mrna Red 1 mra Casma are 5 n hoes uw ey g rre aram f e4 v v ve 3 r fr 5 34 d uw ate oe veie vaa s 2 ue vance oameestes s s s rarte one gt r yat ae iini 2 4 To Search for a Participant Name within the Specific Trial s List of Participants Once you have selected a specific Trial number you will see the Participants Folder in the Left Navigation Tool bar above circled in red To add a Participant start by doing the following 1 Check to see if this person s name is already entered within the trial to avoid duplicate data entry a To verify if your Participant is already in the Trial click Show Browses Research IT Page 11 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Participant Search Fo Wahdrant Com eluted Participant Tra ID Ge 70002 Passe Screening E olled Last Completed vat Enrzcilad Ld Ld Yellow Vint b Type the desired Participant name in the Last Name field Participant Search For Property Matching Pr ert Matching Value um mum i Iu Hos First Name fo Middle Name B Participant Trial Id n Status j Enrolled Date c Click the folder to view enter additional Participant informati
3. Protocol E Last Name First Name MI 8 09 Financials i H O Contracts DOB Age DOD 10 Feb 1970 41 Enrollment Gender Marital Status EJ 014 i Part Info City Home Phone Registration if Full EMR State Province Cell Phone Profile s Drug Items ne m Schedule Country Lo Ethnicity Mi Adding a New Participant one not already in the CTMS Participant Database If the Participant is not found click Create New Participant Participant Search Windows Internet Explorer 2 Last Nama Fist Mama Middle Nama City Dp Pon NYU Bellevue C a 4 4 lt There are no participaers that matched your search criteria Click the NYU Patients checkbox to add the patient to the CTMS Participant Database for entry into future research trials Research IT Page 15 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center http f frfoed med ru edufCinic Tra C TPoolf C TPoolP stertQuckAdd nt anpoPetumToSendereP etum ToSender BProdide CE LSED9CAT AOC EOS30A9 3084 only expose this record to users who have access to this study and permissions to medical records within Please sclect which Participant Pools this new participant record will be associated with Trial Pool will this trial You are creaurg parooparnt record and will
4. Contracts Participants 3 b f Setup O Enrollment e y PAT 001 Part Info Registration Full EMR Profile Drua Items 0 2 Click Save 3 Nextopen the Registration folder Personnel 12 icva 4 e Protocci a O financos O corens s Peciccaccs 45 B ies Enroimert Research IT CTMS User Guide The effects of eating dark c DISREGARD Done Back Save Help History Access Show Loredana Delucchi Office and Treatment Program for Participant Information Trial Id 001 SMITH DOB Address m Page 19 of 46 Last Updated 3 10 2011 Langone Medical Center Now you are ready to enter the Registration information Registration Details for a Specific Participant You are still in the participant s record 1 Click on the Registration screen in the left navigation tool bar within the same participant for which you have been entering data 1 10 147 55 3S ctner eger ation sspicPro Se Box E 15ED9CAZ AOC 4014 SAPS A As intermab3e 40r g 3 The effects of eating dart chocolate Coss face Mele Mister Shes L 7eden6 Delucch Office of Traits World Trade and Treatmert Program for NYC fire Deoatment Rescue Trial 90 9090 O sume Registration Details Persorce 12 System Logged Added Trial 14 02 Dec 2010 2 Informed Content Date Consented By SELE
5. Indicates that the Participant is automatically added to the Trial Pool and is retrieved from the CTMS Participants Database Continue 2 Click Continue The Partipant s Information screen displays Refer to the Entering Participants information section of this User Guide Identify Participant Pools Windows Internet Explorer You are creating a new participant record and will need to identify which Participant Pool the participants will belong to A Participant Pool is a group participant medical records to which specific users may or may not have access to Please be advised that placing participants into pools is granting access to this medical record by anyone who may have access to participant s records in that particular pool Participant Pool Trial Pool 90 9090 CTMS Participants Database Research IT Page 14 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Participants General Windows Internet Explorer The Effects of Eating Dark Chocolate INFOED SYSTEM TEST TRIAL PLEASE E 9 DISREGARD Done Back Save Help History Access Show Loredana Delucchi Office of The IRB World Trade Center Medical Monitoring and Treatment Program for NYC Fire Department Rescue Workers Trial 90 9090 9 Participant Record 8 0 Summary Participant Information 8 06 Personnel 5 i NYU MR Bellevue VA 8 Approvals 1 Participant Trial Id PAT 014 Ex
6. infoEd CTMS User Manual For Clinical Trial Research Management Coordinators and Trial Staff Research IT Last Updated 3 10 11 o Langone Medical Center Table of Contents LOGGING IN SCREEN ORIENTATION LOCATING AND OPENING A STUDY IN CTMS ENTERING PARTICIPANTS ADDING A VISIT PROCEDURE FUNCTIONS HOW TO MARK A VISIT AS COMPLETED CREATING A TICKET RESEARCH ENCOUNTER TICKET APPENDIX A WHAT NEEDS TO BE COMPLETED IN ORDER TO ADD PARTICIPANTS B CONTRACTS AGREEMENTS STATUSES C CTMS TRIAL STATUSES Research IT 10 23 25 31 35 41 41 42 45 Page 2 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Important addresses and phone numbers InfoEd System URL http infoed med nyu edu MCIT Self Service URL http nyumc net nyu mcit OCT Office of Clinical Trials 212 263 4210 Logging In InfoEd can be reached only via the NYU Langone Medical Center network That means you need to be on site or have VPN access to reach the NYU network remotely Tip Access MCIT Self Service via the link above to submit a request for an InfoEd Remote Access Quick Reference The guide describes how to set up off campus access through OnSiteHealth InfoEd Production e The InfoEd server s address is http infoed med nyu edu e To login enter your Kerberos ID and your InfoEd password Screen Orientation Immediately after logging in your CTMS screen will l
7. Errotled E Coreracts Date Consented witnessed G Witnessed Parbopants 4 SELECT B Setup Erroliment 042 Version Date Expiration Date Age at Informed Consent G Pan Did Participant Initial all pages of consent L Registration Full Did Person obtaining consent sign Ic iM ofhle 0 MA i Did Witness sign consent 3 The arm must be identified also a Click the Trial Arm drop down arrow and select the correct Trial Arm such as Arm 1 b Click Save OQ Important The OCT RMC must be contacted for any changes to the arms cycles visits and procedures The Financials gt Procedure matrix has all of the visits and procedures for the trial Trial Arms are treatment groups in a trial Arms contain Cycles such as Screening Cycles contain Visits Visits contain Procedures or services performed on each visit Stratification Criteria Enrollment Enroll Date Enrolled By E Trial Arm 16 Feb 2011 Chris Sandy Research IT Page 21 of 46 CTMS User Guide Last Updated 3 10 2011 Enrollment Date of first Treatment Langone Medical Center Did Waness sign of signed dated consect Gives to Participest t hgibility E gibility Determened Eligibility checklist completed U detertraed ww Eligibility Date Loc stion Camments Failed I
8. j DISREGARDI She 5 4 Derg Back 5 Show Loredana Delacchi of The IRE World Trade Center Medecal Maonitenng and Treatment Program for NYC Fire Department Rescue Workers Trial 80 9050 Participant Record Personnel i _ Trial Can Elbert Coordinator Consent Name Department Roles Certifications Hour ri SaM B Contracts Agreements Statuses ICF CTA used when ICF CTA match and when requested modifications to ICF based on CTA are submitted to IRB for ICF CTA CRMC approval CRMC ICF Needs Reconciliation with ICF CTA language mismatch RMC requests SC make CTA CRMC necessary amendments CRMC Budget Finalized Pending When budget and payment terms are finalized but contract Contract language is still being negotiated CRMC Budget Initial NYU Review 1st review mark up by NYU taking place CRMC Budget Negotiation at OCT Budget is at a middle negotiation and is currently with NYU CRMC Budget Negotiation at Pl Study Budget is at a middle negotiation and is currently with Team PI Study team CRMC Budget is currently with the sponsor any point after the initial Budget Negotiation at Sponsor mark up has been done by NYU and prior to finalization CRMC Budget Waiver of Usual or When any fee or usual budgetary item is waived Comments Standard Fees should note what has been waived and by whom CRMC When a fees waiver is requested Comments should note wha
9. HA E d Visit 100 visit 200 SCR vist Procedures gt Reorder t Screenmg InPsbent Screening Screenica n s5ent Scheduled Cate Viet Completed Date r 27 Viet Completed Sponsor Reg Satsfed Date eJ BUN GRAIN W DIFFUSION PE CAGE Metabolic Panel MRI BRAIN W O CONTRAST AFP Serum Adverse Events toxicities MRI BRAIN W WO CONTRAS Third No Research IT Page 38 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Edit Visit x Visit Name Visit Type C Inpatient Optional Visit isti Screening InPatient M Outpatient 2 Visit Category Billable To Research Indicated Study Account Sponsor Grant Visit Length Participant Instructions 0 00 Sponsor Req Satisfied Date o2 Dec 20 10 These Procedures Events Occur in this Visit ANA 2 Y is ompleted Date 02 Dec 2010 DONN e Change the Visit Completed Date only e Click SAVE the upper right corner The date is now one day earlier 2 Visits Windows Internet Explorer Edit Visit Visit Name Visit Type Inpatient Optional Visit visit One OutPatient v Outpatient r Visit Category Billable To Anoly to all p d T Ty CO d POCeOUF Research Indicated Study Account Sponsor Grant 4 Visit Lengt
10. PE CAGE ictebolie Penel MAI BRAIN gt W O CONTRAST Serum Adverse Events tonic ies MRI BRAIN W WO CONTRAS e Click the Encounter Report Ticket icon to the right of the Visit checkbox The Encounter Report window pops up Research IT Page 36 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Encounter Report Mozilla Fircfox a x Val peeff10 147 58 360754 Fie inn dee Ring ual cn PPrajlD RACFISEDQCAZ AL SESAR SFA SRDA OPEC 1 0C CEMA CCA T9322 1 DEP VE SEALE i 8 NYU Medical Center Bellevue HID GCRC RESEARCH ENCOUNTER TICKET Vie fore simae t bu wor Uic rezcurdi cermin boing Research Project Information Nani ppm Combat 2 717 335 3325 yet menan Anlat PT Emil 9 led Vae Ian yim Prva b derk dicvulatu Department nTv mre Spir Pruul male Radiology uds Research Subject Information Some Fender 14 1 ct Sth eat muhjert Addrnas nan var Wr I1NM gt R Research Encounter Information wur vl Vint Same Suww Utt Type niunt Dale Charge Racearch Items Services cude modifier Printing Tickets u wd uial low suudan Tickle will Lu rulu fur all vurma proweded Uru uf ary eee prup t for catpationt AAND only print eut a rapp nf thie Hrket an
11. c Webpage Dialog Are the Sponsor Requirements Satisfied The date completed will be automatically generated using today s date Open the Research Encounter Ticket and confirm the information as correct Visit Completed Date e The ticket is given to the Patient and emailed faxed or printed to the service provider Visit Partial Date of Service CTMS allows you to complete 2 tickets for a visit If all of the procedures for a visit are completed in 2 days then you will need to do the following First Day 1 Forthe first day uncheck the procedure s services that were not completed using the checkboxes in the visit column Research IT Page 32 of 46 CTMS User Guide Last Updated 3 10 2011 NYU Langone Medical Center t 3 prega Trestmart visn 100 200 SCH visn 2 Procedures NITE Zreree ung inPaceare Scresreng inPstert Soreenms stare L QutPa5ent cl Date Coo ne ed Tete Wat etal Loma Boorse Sac tae s nt Dere BUN MR BRAIN W DIFFUSION CAGE Hetabolkx MRI BRAIN W O CONTRAST Adverse Events Toxscities MEI BRAIN W WO CONTRAS No arem C Sob ec Beleech Curvest Teal 2 Click the Visit Partially Completed Checkbox provided Click on the ticket to confirm the Information as correct Provide the ticket to the Par
12. list window and then press the Open Locate button to display a list of all studies with that sponsor Research IT Page 8 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Opening a Study to Find the Participants Section For this manual we will work with study 90 9090 When you hover over the toolbar screen tips will list the icon function e Click the Participants icon to begin entering Participants This causes a new window to open above our main CTMS search screen c2 E gt f Open articinants Ar seriis Regulatory Financials CRF Data Forward Session Delete The effects of eati d Particin 29 te Loredana Delucchi ABC Inc Office of Clinical Trials Start 27 Mar 2010 90 9090 Participants Windows Internet Explorer The Effects of Eating Dark Chocolate INFOED SYSTEM TEST TRIAL PLEASE ouo s 5 DISREGARD Done Back Save Help History Access Show Loredana Delucchi Office of The IRB World Trade Center Medical Monitoring and Treatment Program for NYC Fire Department Rescue Workers Trial 90 9090 8 0 Participant Record 8 22 Summary H A Personnel 5 Participant Search For amp C3 Approvals 1 sD Financials Participant Bulk Status Change Change status from to 8 h Participant 2 O Enrollmer C3 Activity Log i i CRF Data sD Attachments 2 Classification Codes Pt Summary Additional Info Participant Trial ID Status Passed Screeni
13. need to iderafy which Parnopant Pool the pa toparts wili belong to A Parbopant Pool 8 grouping cf parbopart medical records te which sgpeofic users may oc may nct have access tc Please be advised that phong parvopancs to pools ss granting access to this medical record by anyone who may heave access to records in that peoi ladude Fetiapet Feel Trial Pool 90 9090 CTHS Participants Pool include Participant Pool Trial Pool 90 9090 CTMS Participants Pool Check off the box to Include CTMS Participants Pool Click Continue in the upper right corner The window will close In the new window that opens complete the Participant information The following patient details are required e NYU MR or Bellevue or VA circled in light blue below is required if it is known e Participant First and Last Name and Middle initial e Date of Birth DOB e Gender e Full Address City State Zip e Additional optional Patient Information can be added here as per department policy For example Radiology may enter Ethnicity and Race Research IT Page 16 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Information Windows Internet Explorer Marital Status Home Phone Cell Phone Race American Indian Alaska Native Asian Black or African American Native Hawaiian or other Pacific Islander Unknown o
14. wahota lon e tha Iink 3 I ripa Iimarthaabz tha tk irante EU e nenene 1 lactr 4 alanclar Clinical Trials Search loaned in dice Rarhara Dalsak Tuesday October 05 2010 Powered Dy int infoEd nc TE TNT TTE rip Dess nnl SEET LU S Mn REIS EAE Pumi Atte batles atoms 1 d m M M My Culenudur My Sponsor Lxect Match Set tert Uste p p M p r 4 Uctober 2010 Fm al Tes ob Menatment Y a Fna Mate gt 1 s nuls cof Praasye eres Fuss Math Jaa 48 Iw A 2 earch For Meuh w Approval trevkeny Nuriibwr 9 Personne Cxect March w cet Zponzor Protocol Number 11 12 12 1014 1S Creste New ftatua v Trial Realictratian av 2U 1Y 2U Z1 zz 2J Statuz Macter Triale 24 PA PF 9 ClAaceiteatian Catonnry v 21 x Vrewdear Lffort mg Fam Oct zulu 1 inr My Varus arta Lr Mattar Trialc Action Iteme y Adee d Scurcd My Werifur Map W User My Man My Ibumen Subsects y Contacte ivy There are several options for finding a study in CTMS This section describes
15. y x w B v AE s Withdrawn Completed Remove 1 Now enter the person s Last Name and First Name into the corresponding fields Participant Search Windows Internet Explorer S E NEM Property Matching Value Last Name thompson First Name City Zip Post NYU MR Bellevue Research IT CTMS User Guide Property SSN Gender tocate fclear ali J Create New Participant Matching i lt lt lt If you find any results they will be listed under the Search For section in the Results Subsection and you can view the result by clicking on the Select hyperlink Page 13 of 46 Last Updated 3 10 2011 1 04 Langone Medical Center Participant Search Windows Internet Explorer Clear All 0 TE e Property Value Property Matching Last Name SSH First Name Gender Middle Name DOB City Phone Zip Post Email NYU Bellevue Age Results 1 TE E E Quick 2 Select for Trial ast First Name DOB NYU MR Bellevue Status In the Identify Participants Pool window the Trial Pool 90 9090 checkbox is automatically selected This indicates that the found Participant is automatically added to the trial pool For example Trial Pool 90 9090 CTMS Participants Database
16. 07 127 NYU Cancer Institute O Contracts Sponsor Protocol Number Create Date Start Date End Date Participants 9 xL880 204 09 Feb 2007 06 Aug 2007 22 Apr 2010 AE s 0 Title Bu CRF A Phase 2 Study of GSK1363089 XL880 Administered Orally to Subjects with Metastatic Gastric Cancer OD Attachments 136 D Communications D Contacts Short Title Alerts Reminders Phase 2 study of oral XL880 on an intermittent schedule in diffuse metastatic gastric cancer Calendar Status Phase Type i Site Visits Monitoring 0 Open For Enrollment v Drug Trial E E E e Total participants greater than the number of participants Enrollment Status Off Study Screening Failure Total of Participants to be Enrolled in _ Total amp of Participants Currently Enrolled in this Trial this Trial from ALL Sites not Just Local from ALL Sites not Just Local Proposed of Participants to be Enrolled of Participants Approved to be Enrolled locally in this Trial Locally of Participants Currently Enrolled in this Trial amp of Participants Withdrawn Locally of Participants Remaining for this Trial Locally Research IT Page 41 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center e Inthe Personnel screen the Trial Coordinator Contact must be entered F Personnel Windows Internet Explorer The Lffacts of Lating Dark Chocolate INI OLU SYSTEM TEST TRIAL ILLAS ly
17. CTA is at a middle negotiation and is currently with NYU CTA is currently with the sponsor any point after the initial CTA Negotiation at Sponsor mark up has been done by NYU and prior to finalization CS CTA Partially Executed CTA Hard copies of finalized CTA signed by sponsor NYU received by NYU signatures needed CS Director chooses this when they sign the CTA OCTs CTA Signed by Director contracting end date OCT Dir When a waiver of indemnification or standard subject injury CTA Waiver of Liability Other language is granted Comments should note what was terms approved and by whom CS CTA Waiver Requested When a waiver of indemnification standard subject injury CS language or other term is requested Comments should note Research IT Page 43 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center what is being requested and who is reviewing the request i CTA With OCT Director for Signature When the CTA is sent to the OCT Director for signature CS CRMC CTA With PI for Signature When the CTA is sent to the PI for signature With Sponsor for Signature When the is sent to the sponsor for signature Have received all items needed for initial review contract template Budget template R protocol sponsor contact information dept GO This will generally be the 1st status In Initial Review by NYU seen in the contracts folder Have not received all items needed for initial re
18. all of the searching options that are available to you e The first and most direct way is to enter the Research Number for the study in the Trial Number field e The second way is to search by e The third way is to search by PI and Sponsor Locating Study by Trial Number e Type the Research Number into the Trial Number field e Click Open Locate Note Wildcard Searches You should use an asterisk to denote a wildcard at the end of your search For instance if you re looking for all studies that start with the trial number 07 1 you would type 07 1 in the search value field e The results appear below the main search area Research IT Page 4 of 46 CTMS User Guide Last Updated 3 10 2011 0480 Langone Medical Center Tale Corder Wet DOapemrart 02017 Mas Y ira Serter Frey Meist S bac D a bj Veet oy tee D 1 gt BD LL 12 13 te 12 16 1539 3 Tea 9 ep ito an redis B 19 19 29 213 4px vtero Bree Marter Trials Cnty edt Fg v LE itn w mp arton terma fia ten taps fhe effects of fet cerit iedee M ne fioe of Cheecel Trois Trial Icons The icons to the right of the trial number are the Trial Icons Depending on your level of access some of them may be grayed ou
19. ants 3 Enrollment L Anity ion scis meus Trial ID Status Passed Screening Enrolled Last Completed Visit AE s Withdrawn Completed a 8 PAT 001 Screening v d Visit One 0 D Ga PAT 024 Screening 0 8 E RE RE RE RE 2 Change status from to v i Pt Summary Additional Info Participants Enrolled ForWrials With No Billing Plan Required No of Participants Enrolla 15 digit max Adding a New Participant in the Participants Section Add new participants when the Trial Status is Open for Enrollment See the Appendix section that describes what needs to be completed in order to add Participants This option is located via the Trial Summary screen Click on the Summary option to view the trial status o Refer to the Appendix section for the required fields before adding your participants e Click the Participants icon E1 to begin entering Participants This causes a new window to open above our main CTMS search screen Research IT Page 10 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center 90 9090 The Effects of Eating Dark Chocolate INFOED SYSTEM TEST TRIAL PLEASE DISREGARD Loredana Delucchi World Trade Center Medical Mon Office of The IRB Start 27 Mar 2010 Onthe left navigation bar the Participants folder is bolded The Participants Screen displays listing Participants already entered into the trial ice Qa i E uw
20. c Only one provider displays e Click Apply to All Visits e Click Close im Visits Included in Ac Research IT Page 26 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Add a Provider To add a Provider e Click on the procedure name for the visit e Locate the Service Providers area e Click the sign e Click the drop own arrow to locate the provider name e Click Select Providers Windows Internet Lxplorer Ue Hospital Ballavus Hospital x BHC Ballavus Immunology L Bellevue Hospital x BHC Vascular Lab Blusstons Bone scan Nuclear medicine Rane can Nurclaar medicine Nuclear medicine TH CTSI CTSI x CTST 87 Tisch Satellite CTSI x CTSI Bellevue Husyital CTSI x CTST Seligman Center Cances Institute Cancer nstitute CI Cancer Center 34th St Dexe Scens Dexa Scans Bone densitometry Cancer Ctr Dexe Scens Done densitometry IJD Dexa Scans HCC Sth Floor Faculty Group Practices Faculty Group Practices HGP Pediatnc Cardiology Faculty Group Practices FGP Adult Neurosurgery Faculty Group Practices GP aging Center Associates Faculty Group Practices FGP Anesthesiology Faculty Group Practices FGP Auciology Associates Faculty Group Practices FGD Barlow Memory Eval Cnt Faculty Group Practices FGP Breast amp Surg Oncology Faculty Group Practicas FGD Braast Associates Faculty Group Pract
21. c T v Version Date Expiration Date Did Participant Initial all pages Of consent on Did Person obtaining consent sign IC Did Witness sign consent 2 Type the record details of the Participant s registration process as required below Make sure the Trial ID is correct or edit if necessary Informed Consent Date 14 Feb 2011 Eligibility Eligibility Eligibility Date 15 Feb 2011 a Type the Informed Consent Date b Scroll and type the Eligibility Date Stratification Criteria Enrollment Enroll Date 16 Feb 2011 c Continue scrolling and type the Enrollment Date Research IT Page 20 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center eH Gub d Done Save Help History Access Show d In the upper left corner click Save The Status automatically changes to Enrolled r tp f 10 147 55 3f ctriet CP aen egistr aon apio Profi e 2 CE 156D9CA7 AOCAEDA OATS ADC 46sinternaige E AEGBBAB C27 ZEON g The effects of eating dark chocolate Ld Baci a 9 mutes n u Loredana Deluceh Office of Clinical Trials World Trade Center Medical Monitenng 285 and Treatment Program for NYC Fire Deparzment Rescue Workers Trial 90 9050 Summary Registration Details Personne 16 System Logged Added Trial Id Logged By Status gt O Aserevels 4 02 Dec 2010 2 Chas Sandy o Pretecel 2 OQ financials Informed Consent
22. d Property Trial Number Sponsor Department PI Status Approval Status Classification Category 2 Records Found Results Matching Value Exact Match Exact Match v Exact Match Exact Match Delucchi Loredana Tuesday March 08 2011 Open Locate lear All Property Title Contains Value Start Date v End Date Submission Date 28 aM Approval Tracking Number Sponsor Protocol Number Trial Registration Number External Monitor Show Master Trials Only The Effects of Eating Dark Chocolate INFOED SYSTEM TEST TRIAL PLEASE DISREGARD Loredana Delucchi World Trade Center Medical Mon Start 27 Mar 2010 Office of The IRB 1 Day 1hr v My Action Items Randomized Trial Comparing Peanut M amp Ms versus Regular M amp Ms in Patient with hyperglycemia Test Loredana Delucchi Columbia University Administration Locating a Study by Sponsor e Type the exact name of the sponsor in the Sponsor field or Clinical Trials Search For Uses fur Property Matching Valve Tas Hurbar Eponsor Sepatract Certe gt rogram Ferronne l Acoroval Satur Classcateo Cate ow xact Match Y Exact Math P1 Ener Exact Match Property THe Cortans Set trast Date trd Oats Fubmi
23. d give Etn the cervice prostder at the time nf Service I aratan Charge Item site tUruvider Srd P arl Adult Intuston Center r art J Sburb all us Plow 3rd f adinlaas Payer e Open the applicable study and participant e Goto the Visit section for that participant e Click the Encounter Report Ticket icon to the right of the Visit checkbox e Select Print via the upper left hand corner icon e Click Close to close the window dical Center Bellevue HID GCRC RESEARCH ENCOUNTER TICKET Exporting Ticket to Excel One paused download e When the Research Encounter Ticket is open click the Export to Excel icon to export the ticket in Excel spreadsheet format Research IT CTMS User Guide Export to Excel p Page 37 of 46 Last Updated 3 10 2011 Langone Medical Center Changing the Visit Date of Service If the Visit date is any other day other than the current day such as when procedures are completed in two dates it is necessary to change the Visit Date of Service You are able to change the Visit Completed Date and the Sponsor Req Satisfied Date e Click on the Visit Name hyperlink at the top of the visit column For example if the Participant came the day before the date entered in the Visit change the date by clicking on the visit name at the top of the column ar 1 a firm Fi 8 arm Test tl fe ve acc Receqoenkc e Cycle Screening restmert
24. ent Trial Design important Click the Encounter Report Ticket icon and confirm the ticket for completeness and accuracy Reminder Present the ticket to the Participant and the Service Provider See the Research Encounter Ticket below Research Encounter Ticket The InfoEd CTMS module generates an Encounter Ticket for your participants for each visit you check off as Completed or Partially Completed This ticket details the location s and procedures that a participant will undergo during a visit It is called an Encounter Report This ticket should be printed and provided to the participant to take with them when they get the procedures done Research IT Page 35 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Opening Tickets It is the Coordinator responsibility for the ticket as correct To get to the visit ticket follow these steps e Open your study in CTMS e Open the Participant whose ticket you wish to print e Goto the Visit section for that participant For example your Participant has completed the visit and the visit was marked as complete ene eee SE Eo NI 117 tent visit 100 visn 209 sta visit 2 Visit 3 Procedures Sreeneng inPatent Screening inPatent Screening CutPabent inPatert OwtPatent ma Corina Cota C Complated ipesser fag tasted Oeste 3 D g BUN pr DRAIN W DIFTUSION
25. gsion Date Set Approval Tracking Number Sponsor Protocol Humber Thal Regit ston Humber Master Trials Only Value e To the right of the Sponsor field press Set to look up the sponsor s name using alphabetical pick list window Research IT CTMS User Guide Page 7 of 46 Last Updated 3 10 2011 Langone Medical Center Sponsor Exact Match Browse Alpha Split Mozilla Firefox http inFaed med nvu edurWebPorkallsetBrowseLisk asp zLETTER amp DESC sponsor amp DisplayFormTag spaon name amp ValueFormT Choose sponsor save lose Preferred 8 c DEF 8H I JKLMHOPROQRSIUVMVMWSESXYZ Alzheimer z Association American Cancer Society Inc American Heart Association American Heart Association Heritage Affiliate American Heart Association Northeast Affiliate Arthritis Foundation Burroughs Wellcome Fund Cancer Research Institute Inc Centers for Disease Control and Prevention DHHS Columbia University Damon Runvon Cancer Research Foundation u wie Department of Defense DOD EE A ne paused download Department of Defense DOD Army Environmental Protection Agency Komen Susan 8 Breast Cancer Foundation March of Dimes Morris Philip Companies Inc Mount Sinai School of Medicine MIEHS Duplicate do not use see NIH NIEHS in Preferred list e you ve found the sponsor press the Save button closing the sponsor pick
26. h Participant Instructions Visit Partially Completed Datef Visit Completed Date Sponsor Reg Satisfied Date o9 Ma r 2011 10 Ma r 2011 09 2011 These Procedures Events Occur in this Visit Vitamin amp J Local intranet 10095 7 E e Type the correct Visit Completed Date e Click Save Research IT Page 39 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center e Click Close Show All R eset Milk Chocolate O White Chocolate O Treatment Procedures Visit QutPatient Scheduled Date Visit Completed Date Visit Partially Completed Sponsor Reg Satisfied Date 09 Mar 2011 Research IT CTMS User Guide Page 40 of 46 Last Updated 3 10 2011 Langone Medical Center Appendix A What Needs to be Completed in order to Add Participants In order to Add Participants to your Trial the following must be entered in the Summary Screen e Start Date e Status as Open for Enrollment Summary Windows Internet Explorer 8 O g d A Phase 2 Study of GSK1363089 1880 Administered Orally to Subjects with Study x Metastatic Gastric Cancer 07 12 D Back Save Help Hist A Sho Dr Howard S Hochster Cancer Institute GlaxoSmithKline Personnel 30 Summa amp Approvals 16 C3 Protocol Trial Number E Associated Department 2 O Financials
27. ic Specifically it would be because of PI or sponsor issues that would stop enrollment however it would not imply an IRB imposed suspension Terminated This project enrolling was terminated by PI or Sponsor prior to completing its required enrollment criteria Closed This study completed its contracted enrollment all follow ups are completed all data queries are solved all financials have been accounted for and the study is closed out in the IRB Closed In Long Term Follow up Research IT Page 45 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center This study is closed to enrollment and has a potentially infinite long term follow up phase with no end Patients are followed at some specified time increment for mortality until end of life Closed to Enrollment This study is closed to new enrollment but ongoing enrolled subjects still have visits to complete or data analysis is ongoing Study is still opened in the IRB and continuations need to be completed yearly Withdrawn Withdrawn is used when a Principal Investigator decides he she no longer wishes to submit a research study for review but withdraws it from submission The decision has been made not to pursue opening a project PRIOR to it being open for enrollment The review decision would show Withdrawn Exempt IRB Approved Projects accepted as Exempt in the IRB and do not have any billing requirements that would necessitate a billing plan submis
28. ical Monitoring and Treatment Program for NYC Fire Department Rescue Workers Done Back Save Help History Access Show rial 90 9090 Summary Personnel 10 Screening Approvals 4 Procedures Financials Scheduled Datel 12 Sep 2010 0000000 OO Contracts gt Participants 45 8 Setup O Enrollment uy o42 C3 Part Info Registration Full EMR 8 1 Profile Drug Items 0 L Documents 0 CRF s Third No Bill AE s 00 Activity Log Rtn Care Sponsor H AE s 1 7 Ga cer 3 O Attachments 9 Refresh from Current Trial Design 2 Communications Contacts O Alerts Reminders Calendar Case Report Form Tal Site Visits Monitoring 0 Research IT Page 24 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Procedure Functions Multiple Providers Delete a Provider If Multiple Providers list on an Encounter Report Ticket delete the additional or incorrect provider name s e Click on the procedure name such as MRI BRAIN W WO CONTRAS 2 d TT i AM e T od ai p 2 e Toremove an incorrect or additional provider click the Remove 2 Narrow to the right of the desired provider name Research IT Page 25 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Teisi Institution Charge Telslthenein raais Loss dies cd v wee to
29. ices FGP CT Surgery Assoc Faculty Group Practices F GD Cardiac Catheterizatinn Faculty Group Practices FGP Cardiac Rehab gt Research IT Page 27 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center e Click Apply to All Visits e Click X to close FA PRA Cakaaizs eve sel Places voi Ihe odger enpe co rabie Amormecn Addfienal Componenti io Procedure Charge Tetat Charge E Tatas Charge oe CO Billable The Billable To field indicates who the charge should be billed to for a specific visit procedure Options available for the Billable To field are e Study Account Sponsor Grant e 3rd Party Payer Subject e Non Billable Research IT Page 28 of 46 CTMS User Guide Last Updated 3 10 2011 249 Langone Medical Center To add or change the Billable To field e Click on the specific procedure for the visit such as MRI BRAIN W WO CONTRAS HR GRAIN W DIFFUSPON gt gt CAGE Punt spata Fanet F HRI BRAIN W O CONTRAST Af erum e Click the Billable To drop down arrow and select the correct Billable to option such as 3 Party Payer Subject Calculatiens Maal the Setups to Enable Automate FRA c o6 e c0 Additional Components to Procedure Charge Total Institution Charge 2 00 Total Charge 0 00 2 0 vM MRI BRAIN W WO CONTRAST Addecne Anrbutes Included in V
30. isits Included in Arms Service Providers v wur 100 Art Believes Hospital x amp MC vascular Lab 2 Pu Research IT Page 29 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center e Click Apply to All Visits then click X to close BRAIN wywo CONTRAST Eliminating or Adding a Procedure from a Visit Important At the Visits screen eliminate procedures first as applicable Once a ticket is completed procedures can no longer be added to the visit In the Procedure screen 1 Uncheck the visit to which the procedure no longer applies or check the Visit to which the procedure applies Vitamin A Additional Attributes Included in Visits Service Providers nn Visit One Tisch TH Outpatient Visit Two Visit Category Billable To Treatment 1 Research Indicated Study Account 5ponsor Grant 2 Click Apply to all visits then Close Vitamin A Save amp Apply To First Available Visit mmc n E Procedure Charge Details Research IT Page 30 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center How to Mark a Visit as Completed Creating a Ticket The Visits screen is where you mark off that a participant has actually come in and either partially or fully completed their scheduled visit o Important You must mark your visits complete on either the day when they occur or one or more day s before In order to comply with the trials billing requi
31. n info fejit eben ere Profis orgies 0 77 sthaduie sre ves n TX Courses j Decumers 0 g3 ceno sy Ars hed Actrices Lod Research IT Page 23 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Schedule Mozilla irefox hHp jfj10 147 57 06 ijeneF Pahan ii icherk de asp Prog oc T 1 NSC ATA 4 4d IN LP Sen S 206 EM AIC 1 0C CT 4A MASI INCOR Tri Sen TAi 82 2D ADF OD CT AMATI 1 CCP atient Tah 1 4 The ot eating dark chocolate _ _ _ pc Duus Back Save Helu Histury Ausess Shue Lureilene Delmadn Offux if Clima Trials ARC Tin 90 9090 Irial Summary personnel 6 approvals u Protocol Financials x contracts Participants 32 f seen Fnrallment S 177 Info Registration Full EMR ll profile nn t E set visits iM TX Courses Durvwnenls 0 Schedule Set vizit Schedule cyde Visit Name Visit Date Relative xo the first visit Visit Range Reminder Meviatinn Visit ZUU Activity Log e Click on the Visits folder to continue http 10 147 55 35 ctnet PatientMatrix aspx ProjID 82CE 15ED9CA7A0C4E0430A93264FAD0C4 amp sInternalld 84BEAB3B8A81C272E0430A93264FC2728 amp PatientsTab 1 ie B o d 8 The effects of eating dark chocolate Study Loredana Delucchi Office of Clinical Trials World Trade Center Med
32. nchesien Criteria O Criteria Sumber Failed Exchssion Criteria com Criteria Sumber Waiver MEE Net Registered C Reason ratifst atian Criteria Enroll Date Enrelied Randemi ates Rahdas2i7 etian Date Withdrawe fy gt Date of Last Treatment w o Ho Done Back Save Help Trial 90 909T 35 H History Access Show e Inthe upper left hand corner click Save Research IT CTMS User Guide Page 22 of 46 Last Updated 3 10 2011 Langone Medical Center Adding a Visit Schedule Set The Schedule Set screen is where you assign visits to a participant by selecting one or more cycles from the pull down menu and then pressing the add icon e Inthe left hand navigation menu find and click Schedule Set e Click the drop down arrow and select the desired cycle such as Screening e Click to add the cycle This will add all of the visits that have been assigned to that cycle Only add cycles as the participant goes through them Schedule gt E x hip 147 55 Poienari FS Aa TC Tri raa LECT rt T abe 1 Boueo s 4 t gaas tais Mistery Access Stew Loredana Detects Office of Chrecal Trais ABC Inc St sete Trial 2 2090 LJ summary Schedule Set Persornel 02 Approvals Preteen Finch contracti Pascperts 32 Stag mot oi
33. ng Enrolled Last Completed Visit AE s Withdrawn Completed Remove gp 001 Screening v w visit One 0 n gp PAT 024 Screening 0 0 Regulatory Comp Participants Enrolled For Trials With No Billing Plan Required No of Participants Enrolled 15 digit max Research IT Page 9 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center Entering Participants Important Contact your Assigned from OCT Office of Clinical Trials to determine if you need to enter the Number of Participants Enrolled or enter Study Participants individually as below Entering the Number of Participants for Studies with No Billing Plan Required Follow the steps below for studies with No Billing Plan Required such as for survey or registry studies Onthe Participants screen Participants Enrolled for Trials With No Billing Plan Required box No of Participants Enrolled box type the correct Number of Participants Enrolled Participants Windows Internet Explorer The Effects of Eating Dark Chocolate INFOED SYSTEM TEST TRIAL PLEASE 9 DISREGARD Done Back Save Help History Access Show Loredana Delucchi Office of The IRB World Trade Center Medical Monitoring and Treatment Program for NYC Fire Department Rescue Workers Trial 90 9090 oO Participant Record O Summary O Personnel 5 Participant earch For O Approvals 1 D Financials Participant Bulk Status Change 43 Contracts ff Particip
34. on Participant Search For Property Matching Matching Value Last Name First Name Middle Mame Participant Trial Id Status Scheduled Date Enrolled Date p Participant Bulk Status Change Change status from to Participant Trial ID Status Passed Screening Enrolled Last Completed Visit AE s Withdrawn Completed m lar 001 Withdrawn Visit Beta o 004 Dropped Visit Alpha m lage 232 008 Completed Visit 20 Pt Summary Additional Info No of Participants Enrolled 15 digit max If the Participant is found skip to the Entering Participant Information section Research IT Page 12 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center If the name is not in the Trial please check to see if the person is associated with another Trial and has his her name already listed within the listing of all Participants in the CTMS Participants Directory in the Infoed System by clicking on the Plus Icon EJ Participant Search For Property Last Name First Name Middle Name Participant Trial Id Status Enrolled Date Participant Trial ID Matching Value Property v Phone Home v Fax B Scheduled Date 2 Status Passed Screening Enrolled Last Completed Visit Pt Summary Additional Info i5 digit max No of Participants Enrolled 55 digit max Screening Failure Limit Matching gt
35. ook like below Note Your left Navigation Tool Bar options will vary based on what modules to which you have access Mozilla Hiretox Yew S Helory X Aa hatp Jsinfoed med nyu edufwebPortalique aspr2x st k dba 2 S Latest Headines Academe NYULMC2 IE Prod TE Tost Training 2 Education Crupaiwebste login gt The Link Eclipse Timeshects The Link 7 Crants qov EEG cna commons Exctr cocoge caendo http infoed med ue asp Stat Upen wd m Durburu Duisuk lule NS 20n1n Find Fundinq te CV Databasc e Ry 1 Kecard and P E My Open Actiun Ilern gt Durburu Duisuk Ttem Tyne Martetanadting reviews Action Reoqdred Wediuewadey Merd US ZUXU HS Prutul tel Live Pew Jo ali 11 35 57 am My Trl My Human Suih feet My Profile Aden tan e Immediately after Logging In you will click on My Clinical Trials Research IT Page 3 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center Locating and Opening a Study in CTMS e Click on the Search For screen NIDLIMEMICEUCUUBIES LH crp E Yaw Huglory BEoheagbh b fal http finrocd mcd nyu cdufWcbPortal Main azp7 Mod cec T L amp Syztemesc T vz 1582 D Iaat DE 7 NAEM weed nine 1 irahan c Donal
36. r not Reported white or Caucasian 1 Inthe upper right corner click Save Notice the changes in the Left Navigation Tool Bar area Before entering the information about the Participant there is no name in this field P tp finfoed med nryu edu patient PatientMan asp ReturnToSender R eturnToSender BProjid e amp 2CE SEDSCA7 ADC 4ED4 30A93264F AOC 0 Information NYU MRe m Last Name First Name After clicking on the SAVE button the name of the Participant appears here An EMR Electronic Medical Record is created Research IT Page 17 of 46 CTMS User Guide Last Updated 3 10 2011 2 In the upper left hand corner click Done to exit this screen Entering Participant Information The new Participant is now added and you are returned to the Trial Folder view and the new Participant Information screen P tapan pprt Nee F 7 Boch or ramcn or other Ford slender l abasas or aam or Cameco Research IT Page 18 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center 1 If you wish to edit the Trial ID assigned by the Infoed system delete the 8 that is there and assign the Trial ID relevant to your Trial for that Participant it is a unique identifier s Trial 90 9090 Summary Personnel 14 C Approvals 0 Protocol amp Lj Financials
37. rements the Office of Clinical Trials requires that you mark your visits complete either ahead of time the day before or on the day that the visit occurs o If the participant cancels a pre marked visit you have until that scheduled evening of the visit to return to CTMS and uncheck the visit o If you miss marking off a visit you should call your OCT contact to let them know of the late visit recording Visit Completed The Participant came and did everything that was required and the visit was completed e Check off the Visit Completed checkbox if all of the procedures for the visit were done jC USE es eo visu 200 wisst 760 c vis 2 wrest d Procedures Zcrneerergg Inf eters ee g InPaboert Screereng cP aber ir mim Out Pacers a E SD C moms mo Sac 5a s a atu 06 Oct 2016 FUN PHALA CAGE Ld 2 09 og 2 09 aa FPA 7 el5 Pane MEI GRAIN W OD CONTEAST AFF Secum sod f 2 58 Adverse fwents tewicities E y pa 2a HEI SAT Ws CONTEAS D Do A message pop up will appear asking if the sponsor requirements were met e Click OK or on some browsers click Yes in response to the pop up screen stating the sponsor requirement for this visit were completed Research IT Page 31 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center Microsoft Internet Explorer
38. sion to the OCT Research IT Page 46 of 46 CTMS User Guide Last Updated 3 10 2011
39. t Budget Waiver Requested is being requested and who is reviewing the request CRMC CTA BRANY CTA and Partially When OCT receives fully executed CTA and Partially Executed Executed Study Memo received Study Memo from BRANY NYU signatures on Study Memo by NYU needed Research IT Page 42 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center BRANY with NYU for When NYU receives near final CTA and or Study Memo from approval BRANY for approval prior to execution CTA BRANY negotiating CTA is in negotiation by BRANY CTA language budget payment terms has been finalized and executable copies are being reviewed by CRMC prior to CTA Final CRMC Review Directors signature CRMC CTA Final CS Notes and For CS to document final notes and exceptions including any Exceptions waivers related to contract language CTA language budget payment terms has been finalized and hard copies are being reviewed by CS prior to Directors CTA Final CS Review signature When contact language finalized but budget is still being CTA Finalized Pending Budget negotiated Fully Executed Agreement When OCT receives fully executed signed by all parties CTA Initial Review Initial contract language mark up by NYU taking place CTA Language and Budget Finalized Awaiting Executable Copies Awaiting for executable copies of final CTA from sponsor CTA Negotiation at NYU
40. t indicating that the function is not available to you Specifically the delete trash icon is normally not available to non module administrators 90 90900 The effects of eating dark chocolate Loredana Delucchi Inc Office of Clinical Trials Start 27 Mar 2010 90 9091 TEST Trial Loredana Delucchi ABBOTT NYU oM Information Technology Start 62 hiad 2616 e f you do not enter the exact Trial Number you will get a results list of every study whose Trial Number is a partial match to what you entered Locating a Study by PI Name e Type the last name of the PI into the PI field such as delucchi e Press the Open Locate button Research IT Page 5 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center od 2 Clinical Trials Search For 6 dh Page 9 Tools NYU SoM InfoEd Logged in User mr infoed pil Tuesday March 08 2011 Test Portal Find Funding CV Database Powered B Clinical Trials Search For infoEd Use for wildcard InfoEd International Inc Property Matching Value Property Value ET sl Trial Number Exact Match Title Contains My Calendar My Clinical Trials Sponsor Exact Match Start Date 2011 GJ show List Department Exact Match End Date j Search For enter Prograrr det Ma ubmission Date v Report On i pproval Tracking Number
41. ticipant and to the Service Provider Second Day These steps are for the second day of the visit when all procedures have been completed For example the participant came in for the first day with procedures Adverse Events toxicities and MRI BRAIN W WO CONTRAS completed During the second day the participant had the remaining procedure s done e For the second day click checkboxes for the remainder of the procedure s to indicate done All procedures should be completed the second day Research IT Page 33 of 46 CTMS User Guide Last Updated 3 10 2011 e Check off the Visit Completed checkbox e Amessage pop up will appear asking if the sponsor requirements were met e Click Yes The date completed will be automatically generated using today s date Research IT Page 34 of 46 CTMS User Guide Last Updated 3 10 2011 Langone Medical Center S reanins Procedures ETT en Visit 200 SCR Screening InPabent Screening InPatient OutPatiert Scheduled Date Receqoen ef Cycle Treatment Viet Completed Date 11 NM n n P D Visit Partially Complatez D e n o Sponsor Rag Sansfied Date 08 Oct 2010 n n D p Ly d MR BRAIN W DIFFUSION aaa T Cy EP Metabolic Panel APP Serum PO o CE EP od RI BRAIN W WO CONTRAS 0 C Third No Gull Rin Zare Sponsor Refresh from Curr
42. view should Pending Initial Review list what is missing Transferred to Another Contracting Office When negotiation transferred after Day 0 documented CS CRMC CTA language and or budget never finalized or withdrawn Withdrawn Never Finalized closed before site initiation CS CRMC Research IT Page 44 of 46 CTMS User Guide Last Updated 3 10 2011 o Langone Medical Center C CTMS Trial Statuses These are various statuses available in CTMS and what they mean They are presented in approximately the order of a study s approval process lifecycle Pending Pre PRMC approval No regulatory or contractual work has begun yet Under Review PRMC approved initial work has begun from a regulatory financial and or contractual perspective Multiple approval groups need to review and give their approval to the study before it can be opened to enrollment Open to Enrollment All required approvals have been received and documented This includes all institutional and group approvals the grant or contract has been executed the study visits have been built and CTMS is ready to receive enrollment data Disapproved Something or some group has not OK d the project and no further reconciliation is being attempted to open this study at this time Suspended A research study is stopped or suspended by the IRB for regulatory human subject or other concerns Enrollment on Hold Any reason a trial is put on hold other than IRB specif
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