Participant Tracking Database User Manual v1.0
Contents
1. Recruitment Sources and Health Workers is used by the system to create drop down lists on the Participant Information Form see Section 6 below While Recruitment Sources and Health Workers must be entered before any participant specific information can be entered this information can also be added to or updated at any time during the course of the study 5 1 Recruitment Sources If sites wish to use the database to track sources of participant recruitment the site must assign code numbers to their participant recruitment sources the method by which the participant was recruited The recruitment source code number is then entered for each participant on the Participant Information Form To initially enter or update Recruitment Source code numbers from the Data Entry Menu Click the Update Recruitment Sources button Enter the source s code number and name in the boxes on the Recruitment Sources Form You can also search for a Recruitment Source record by clicking on the arrows at the bottom of the form and edit that information as needed Close the Recruitment Sources Form by clicking the Close button Note Once a recruitment source code number has been assigned to a particular recruitment source the code number should not be deleted from the database or re assigned to another recruitment source There is virtually no limit to the number of recruitment sources that can be entered into the database 5 2 Health2. Late amp Missed Visit Reports Participant Tracer Report To review reports within these categories click the button beside the desired category on the Reports Menu 9 1 Screening and Enrollment Reports Click on the Screening amp Enrollment Reports button on the Reports Menu to open the Screening amp Enrollment Reports Menu There are six report options available on this menu 13 Participants with Two Weeks Left to Enroll Participants with One Week Left to Enroll Screening amp Enrollment Report This report shows the number of screened and enrolled participants for the preceding 7 days and cumulatively by month Screened amp Enrolled Participants This report is a cumulative list of participants that have been screened and enrolled per month Participant Early Termination Report This report is a cumulative list of participants whose status early termination on the Participant Information Form Enrollment Yield by Recruitment Source This report lists the number of screening and enrollment visits completed due to each recruitment source and enrollment yield 9 2 Scheduled Visit Reports Click on the Scheduled Visit Reports button on the Reports Menu to open the Scheduled Visit Reports Menu There are six report options available on this menu Scheduled Follow up Visits for Selected Day This report allows you select a date in order to see follow up visits that are scheduled for that particular day
3. List per calendar month screens of enrollments Generate a follow up visit schedule with dates Excel Tool Tell you which PTIDs have visits coming up on which day and what type of visit Tell you which visits a PTID has missed Tell you which visits for which a PTID is late Tell you which PTIDs have terminated early Inform which recruitment sources are most effective at yielding enrollments RON RN A KSAS 1 2 What the database cannot do Indicate what procedures are required at a visit Tell you if a participant is enrolled in MTN 015 or is currently pregnant Be used for co enrollment identification Allow for separate dates for split visits to be entered Cannot trigger reminders for second half of split visits Allow you to generate retention rates Be used as source for any information All information should be documented in other places Tell you which participants attended the clinic on days prior to today Synch data with Outlook calendars Flag if a visit is scheduled outside of its windows 2 Equipment Equipment consists of one security encrypted Hewlett Packard HP 1104 Mini laptop computer and an external mouse per site Information on the security encryption phrase required to be typed in each time the laptop is turned on will be provided to each site separately at the time the laptop is supplied
4. participant s current status from drop down list The default value is Screening Be sure to update if a participant withdraws consent is lost to follow up or becomes ineligible during the screening process Mark Invalid PTID Entry if a PTID was entered incorrectly or if two entries were created in the database for the same participant If this occurs please mark in the comments box that the entry was created in error If a participant terminates early at any point during the study update her status to Early Termination The next section of this form contains optional fields to enter a participant s home and or mobile phone number and checkboxes to indicate whether the participant has given permission for the clinic staff to contact her The last section of this form is a Comment field This field can be used to record relevant administrative or study management information for the participant such as preferred primary language and Date of Birth No medical information should be entered in this field To add another participant Click the Add New Participant button at the top of the form or the button at the bottom right of the Record Navigation bar of the Participant Information Form After entering all participant information close the Participant Information Form to return to the Data Entry Menu All data entered will be automatically saved 6 2 Updating Participant Information To update participant informati
5. MTN 020 Participant Tracking Database User s Manual Version 1 0 June 2012 Disclaimer The MTN 020 participant tracking database is an optional tool provided to study sites by SCHARP for use in study visit management visit tracking purposes This database does not collect or store any data used for study analyses and this database will not be transferred shared or provided to any persons outside of the study site This database is not used to record collect source data or generate source documents All information entered into the database is based on source documents contained in participants study records Information contained within the database or printed from the database is not source data or documentation As with all study data every effort should be made to maintain participant privacy and confidentiality This manual and the MTN 020 participant tracking database were developed by SCHARP and FHI 360 with input from the MTN 020 study team Please direct questions about this manual to the following individuals Jennifer Berthiaume jberthia scharp org Table of Contents k NT OCU CHO Macatee sickest cea eeehta N element E ee eee tee 4 ck Wat the database CAN dO erra E E A 4 k2 Whatthedatibase cannol CO sisene O mesic 4 Dx EQUUM O enaa a a a a T 5 3 Password Protection Access to the Database ccccccccccccccccccccceeeeaeeeeeseeseeeeeeeeeceeeeeeeeeeeaaaaaaas 5 4 MS Access Basics Tips for Navi
6. Scheduled Follow up Visits Next 2 Weeks Scheduled Follow up Visits 2 Weeks Out Scheduled vs Actual Visits Monthly This report tabulates the number of visits scheduled the number of visits completed and a raw participant follow up rate on a monthly basis Scheduled vs Actual Visits by Health Worker Participant Visits Requires PTID 9 3 Late and Missed Visit Reports Click on the Late amp Missed Visit Reports button on the Reports Menu to open the Late amp Missed Visit Reports Menu There are two report options available on this menu Participants Late for Follow up Visits visit window has not yet expired Missed Visits 14
7. Select from the drop down list If the relevant Recruitment Source is not on the drop down list enter the Recruitment Source in the database by following the procedure in section 5 1 e Screening Consent Date Entering the Screening Consent Date is very important because this date is used by the database to determine the last possible enrollment date allowed for this screening attempt Always double check the accuracy of this entry e Enroll by This field is automatically generated by the database based on the Screening Consent Date e Enrollment Randomization Date Entering the Enrollment Randomization Date is very important because this date is used by the database to determine the target date and allowable visit window for each of the protocol defined follow up visits Always double check the accuracy of this entry e Health Worker 1 If Health Workers are assigned at your site select from the drop down list Otherwise leave this field blank If the relevant Health Worker is not on the drop down list enter the Health Worker s name in the database by following the procedure in section 5 2 e Health Worker 2 If two Health Workers are assigned at your site select from the drop down list Otherwise leave this field blank If the relevant Health Worker is not on the drop down list enter the Health Worker s name in the database by following the procedure described in section 5 2 e Participant Status Select
8. The participant tracking database has been installed on the C drive of the laptop computer SCHARP is providing the laptop with the database installed in order to avoid software computability issues and or computer hardware issues that could affect the performance of the database The above listed equipment may be used for purposes of running the participant tracking database only The equipment should not be used for any other office business or leisure activities No additional software should be installed on the computer and the computers should not be used for word processing browsing the Internet or any other application No technical changes should be made to any of the equipment unless directed by SCHARP In particular please ensure that the original version of Microsoft Access 2010 remains on this laptop and later versions of Microsoft Office Suite and Windows are not installed at any time during the study Since a laptop with the database will be provided in working order SCHARP is not responsible for any data loss and or future technical or software support needs incurred by the site To best protect participant confidentiality the database should not be backed up or stored on another device location If all or part of the database is lost or damaged it should be possible to re enter re create the database if the site chooses as the database is not the source for any of the information it contains all data can be entered based on s
9. Workers If Health Workers are assigned to specific participants at your site and you wish to keep track or be able to Know which workers are assigned to which participants you may enter the names or initials of the Health Worker assigned to each participant in the database As a first step you must enter the Health Workers names in the database to create a drop down list in the Participant Information Form To enter or update Health Worker information from the Data Entry Menu Click the Update Health Worker button Enter the worker s name full or partial or initials in the box on the Health Worker Form You can also search for a Health Worker record by clicking on the arrows at the bottom ofthe form and edit that information as needed Close the Health Worker Form by clicking the Close button Note Once a Health Worker has been entered in the database that person s name should not ever be deleted from the database even if that worker stops working on MTN 020 7 Adding and Updating Participant Information Participant Information should be entered into the database upon initial screening You will need the participant s study ID number PTID to begin entering data Each participant with a PTID will have a single record in the database If a participant screen fails or fails to enroll during the allowable window yet is deemed suitable for further consideration and re screening update the appropriate fields for exampl
10. e Screening Visit date Enrollment Visit date for 2 screening attempt in the participant s existing records and proceed accordingly 6 1 Initial Entry of a Participant To add a new participant from the Data Entry Menu Click the Add New Participant menu button This opens the Participant Information Form in a new record where you can begin entering a participant s information P E Participant Information Form SEa 2C Marticipan armator Find Participant Add New Participant Schedule Follow up Visits PTID Recruitment Source Screening Consent Date Enroll by Enrollment Randomization Date Follow up Schedule Health Worker X Health Worker 2 Y Participant Status Screening x Contact Information Participant Mobile Phone E Mobile phone call OK Home Phone f Home phone call OK Participant Comments Do not enter any medical information pertaining to the participant Record 14 lofi is Mo Filter Search Figure 1 Participant Information Form The first section of this form records information about the participant Fields on the form are e PTID Enter the participant s assigned MTN 020 PTID Once a PTID is entered into this field a message box will appear asking to verify that this PTID is correct If an invalid PTID is entered into this field an error message will appear e Recruitment Source
11. esavanediasevineddaneanacians iatesasanediices yee ianaies 13 92 SENCGUICG VW 1810 RCP OTS iateccssuara retusa derccsta ea sirtudacacaltoed vote aaadcraslte tualel del cndecsuotiveliiandee Seu etuebuaes 14 9 Eateand Missed Visit Re Ons oen EEE 14 1 Introduction The MTN 020 participant tracking database is a Microsoft Access application used by MTN 020 site staff to assist in a number of study administrative and management functions including e visit scheduling and tracking e identifying study participants who are due for visits in order to conduct visit reminders e identifying study participants who are late for or have missed scheduled visits in order to conduct timely participant outreach and retention efforts Output from the database consists of Microsoft Access reports Use of the database is completely optional and is in no way associated with collection management or storage of data that will be used for analytic purposes vis a vis the MTN 020 study objectives Note The database is to be used for participant tracking purposes only It should not be used to record source data or generate source documents All information entered into the database is based on other source documents contained in participants study records Information contained within the database or output reports printed from the database are not source data documentation 1 1 What the database can do Let you know when Enrollment Visits are coming up
12. f30 gt M pii WK No Filter Search Figure 2 Follow up Visit Master Log i O5Sep 7 cay oe Toa The lower portion of the Follow up Visit Master Log contains the Follow up Visits Subform This subform contains the fields listed below This subform is tabulated based upon the participant s enrollment date The information on this subform is duplicated on the follow up schedule which can be printed for each participant s binder The Scheduled Visit Date Actual Visit Date and Missed Visit fields can updated during the study at any time Follow up Visit Month The follow up visits will appear in the Follow up Visit Month box Visit Month The visit month will appear in the Visit month box Target Visit Date The target date will appear in the Target Visit Date box This is pre filled based on the Enrollment date and cannot be changed Scheduled Visit Date The scheduled visit date will be entered in the Scheduled Visit Date box This date is based upon your clinic schedule and the participant provided the scheduled visit date falls within the allowable visit window Enter the scheduled visit date as agreed upon with the participant Actual Visit Date After a visit takes place enter the actual date of the visit on the Participant Check in Form or on the Follow up Visit Master log Missed Visit Mark this box if the visit window for a scheduled visit has passed and the participant has bee
13. gating the Database ccccccccssessesececeeceeaeeeseeeeeeeeeeeaaeeeees 6 5 Non Valid Dummy PTIDs for Initial Testing of Database noeessseoeennssssssssererssssssssseersssss 6 6 Entering Participant Recruitment Sources and Health Workers cccccccccccccceceeesseeeeeeeeeeeeeees 7 Sel ANCCHUILIMENL SOULCES saroian E N E Ned eaeneted eee 7 Diz MELO ANE WW OFC US ena E ace cmiontotaasasteneatien teenies aceb anion tendons aiennauenteeesocyaes 7 7 Adding and Updating Participant Information ccccssseeeeeecceceeceeaeeseeeccceeeeeaaeeeeeeeeeeeeeeaas 8 OA InitialiEntry of 4 Participant sacssnteutasettodwaleudinetaiiomieaiwetiediealeadinantanieinatiimalndiaats 8 6 2 Updating Participant Information ccccccccccssssessseccceecccaeesseeecceeeeeesesesesecceeseesaaaeeeeeeeess 10 8 Generating Participant Follow up Schedules cc cceescsecccceceeeeeeseeecceseeeeaeeeseeeeceeeeeeeaeeeeees 10 9 Manacine Participant Follow Up Visits sivcsssanecttesecoveasadasedeatnnedsnseeenidediueweanaarediatneendatedeeetedien 11 8 1 Checking Target and Allowable Dates for Follow Up Visits nnneosssssssoeenssssssssseersssss 11 82 scheduling Folow Up Vissies n E O A 11 8 3 Entering Completion of Follow Up VISIts sserisiniiesnnuiedieod nnn ade 12 FO Generating ROPO S aian sia sias eae cts dancdsinces ahi adenen ease aeeiatens 13 91 Screening and Enrollment Reports visscazsscionctesasensanes st
14. n unable to attend her scheduled visit for that month Close the Follow up Visit Master Log All data will be saved automatically 8 3 After a Entering Completion of Follow Up Visits follow up visit takes place Click the Participant Check in Form button on the Main Menu The Participant Check in Form will open 12 f Participant Check in Form 53 77 88888 2 Find Participant Follow up Target Visit Scheduled Actual Visit Month Date Visit Date Visit Date 1 6 14 2012 14 May 12 14 May 12 6 11 2012 12Jun 12 13 Jun 12 7 9 2012 10 Jul 12 9 3 2012 10 1 2012 ee 10 29 2012 ee vote nis is not a record c Fompletec BShinge 2 3 4 6 6 2012 5 6 Record H 1 of 30 gt gt I amp Mo Filter Search Previous Participant Next Participant Figure 3 Participant Check in Form All fields on this form are locked for edit except the Scheduled Visit Date the Actual Visit Date and the Missed Visit checkbox Enter updated scheduled or actual visit dates in the appropriate boxes Or if a scheduled visit is not completed before the allowable visit window elapses check the Missed Visit box Close the Participant Check in Form by clicking the close button All data will automatically be saved 10 Generating Reports To generate database reports return to the Main Menu and click on the Reports Menu button Reports are grouped in four categories Screening amp Enrollment Reports Scheduled Visit Reports
15. on From the Data Entry Menu click the Update Participant Information button This will open the Participant Information Form To search for the participant whose record you would like to update Click the Find Participant button at the top of the form This opens a Search Dialog Box By using the Find What box you can search for any entry in any field e g all or part of the PTID participant name or nick name street address etc To search a fields at once select Participant Check in Form from the Look In drop down box select Any Part of Field from the Match drop down box and selecting All from the Search drop down box If searching by full participant ID be sure to include the dashes Click the Find Next button to execute search Once you have located the correct participant s record edit the Schedule Visit Data Actual Visit Date or Missed Visit fields as needed Close the Participant Information Form to return to the Data Entry Menu All edits will automatically be saved Generating Participant Follow up Schedules The database will generate enrolled participant specific follow up visit schedules based on the enrollment randomization date entered on the Participant Information Form The generated follow up schedule includes the participant s PTID her enrollment date and all of the following for each required follow up visit target visit date visi
16. ource documents maintained by the study site If the site makes any modifications to the database and or other software or makes any changes to laptop hardware network connections etc the site is responsible for any effects these modifications have on the participant tracking database Password Protection Access to the Database To maintain participant privacy and confidentiality the database must be maintained in a secure environment Password protection should be established for each authorized database user by following these steps Open Microsoft Access A Password text box will prompt you to enter a password before you can access the database Type the password given to you during the site specific training Click OK Be sure to record all passwords in a secure location away from the machine on which the database is installed 4 MS Access Basics Tips for Navigating the Database To open the database Double click the MTN 020 Participant Tracking Database shortcut or icon present on the desktop The database is a menu driven MS Access application As such navigation within the database is based on user selections from options on a series of hierarchical menus The top level menu which greets users upon entry is called the Main Menu From the Main Menu users can select from multiple submenus Some of these submenus have their own submenus while others have options for data entry forms or reports Like in o
17. ow up Visits button on either the Data Entry Menu or the Participant Information Form The Follow up Visit Master Log will open Click the Check Visit Target and Window button on the participant s Follow up Visit Master Log Enter the relevant visit month and hit Enter to display the target and allowable dates for that visit 8 2 Scheduling Follow Up Visits To record scheduled dates for follow up visits Click the Schedule Follow up Visits button on either the Data Entry Menu or Participant Information Form The Follow up Visit Master Log will open Locate the desired participant record by clicking on the Find Participant button This will open a Search Dialog Box You can search by PTID or by participant name Remember to search a fields at once select Participant Check in Form from the Look In drop down box select Any Part of Field from the Match drop down box and selecting All from the Search drop down box If searching by full participant ID be sure to include the dashes Once you have located the correct participant close the Search Dialog Box The top part of the Follow up Visit Master Log contains data populated by the Participant Information Form You cannot change any participant information on the Log all changes must be made on the Participant Information Form as described in section 6 2 11 Follow up visit Master Log jme e a Record A 4 1o
18. t window start open date visit window end close date scheduled visit date actual visit date It is recommended to generate the schedule for each participant upon enrollment for use as a tracking tool in each participant s study notebook Subsequent generations of the schedule generated after follow up visits have taken place will contain data on scheduled and actual visits based on information entered on the Fo low up Visit Master Log form as described in section 8 Access the participant s Participant Information Form as described in section 6 Click on the Schedule Follow up Visits button on the Participant Information Form The Participant Follow up Visit Schedule opens 10 Note that the participant information including Screening Date and Enrollment Date cannot be edited in this form This can only be edited in the Update Participant Information form as described above in section 6 2 Managing Participant Follow Up Visits Follow up visits can be scheduled and managed for only those participants with a completed Participant Information Form In particular the form s Enrollment Randomization Date field must be complete 8 1 Checking Target and Allowable Dates for Follow Up Visits To check the target date and allowable visit window for a specific follow up visit consult the Participant Follow up Visit Schedule previously generated for the participant see section 7 0 Alternately Click the Schedule Foll
19. ther MS Access applications navigation among records in the database is accomplished by use of the Navigation Bar at the bottom of each form The Navigation Bar indicates the number of existing records and offers 5 navigation buttons takes users to the first record to the previous record to the next record gt I Ito the last record to a new record When closing a form within the database use the Close button rather than the x at the top right of the form It is fairly easy to confuse the x on the intended form with the x on the Access window leading to the unintentional closing the entire database 5 Non Valid Dummy PTIDs for Initial Testing of Database Nine non valid PTIDs are available to be entered so that the database may be tested prior to study start The following dummy PTIDs can be entered along with dummy screening and enrollment dates to experiment with different components of the database 999 99999 1 999 99999 2 999 99999 3 999 99999 4 999 99999 5 999 99999 6 999 99999 7 999 99999 8 999 99999 9 If sites choose to enter these PTIDs for testing and training purposes please ensure that these PTIDs and any associated information are deleted prior to study start 6 Entering Participant Recruitment Sources and Health Workers Before any participant specific information can be entered in the database some other information must be pre populated in the database This pre populated information
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