Ethics Utility User's Guide
Contents
1. View Trials and Overdue Reports Jlease search for a centre and trial For EREP CENREP this button will bring the user to a screen showing all trials that are available through the utility at the centre For ECRA PCRA this button will bring the user to a screen showing all trials that are available through the utility at the centre for which the user is included on the current trial participants list Ethics Utility User Gears Location Main Trials and Overdue Reports Legend Colour Meaning OK lt 30 days Attention 31 60 days Needs Action 61 90 days MAJOR gt 90 days Please click on the headings to view addtional details for the trial CAXX ALC 1 Next Annual Ke approval is due 11 59 59 PM on 2010 SEP 26 Doc Reference Reference Date Sent Date Due Level of Local REB Type Number Date to Centres Review Req d Approval Date AM REVISION 6 2008 MAY 01 2006 MAY 30 2008 AUG 26 EX CAXX BL 8 No Annual Re approvals are required No Overdue Documentation Page 5 of 12 Items that are outstanding or coming due will be identified by colour in accordance with the legend If the current annual re approval for the trial is outstanding it will be indicated in red The user can access the trial specific ethics utility screen shown in section 3 by clicking on the centre code trial code Click here to access the trial specific ethics utility screen for this trial CAX2. Other Ethics Review Documentation Legend Colour Meaning OK lt 30 days Attention 31 60 days Leg e nd _ Needs Action 61 90 days MAJOR gt 90 days English English French Other Level Level Doc Reference Reference Date Sent Men Consent Tissue je Tissue of Date Sent Type Number Date to Centre Due Version Banking Version Date Banking gt Review Review to Centre Date Consent Date Consent Date Req d Rec d co 1 200 SEP 2007 SEP 27 200 NON FB 27 10 co 2 2008 FEB 2008 FEB 29 2008 APR EX 29 01 co 3 2008 APR 9908 APR 29 2000 MAY EX 29 13 co 4 2009 SEP 22 ANR EX 2009 OCT 2010 JAN 2009 OCT NCIC 5 14 12 14 REVISION 5 2009 SEP 2008 0CT 2010JAN 2009 DEC lang nec 46 2009 OCT 2009 JUL 2009 OCT 2009 JUL 08 06 2009 JUL 08 04 08 2009 MAR 2009 JUN 2009 MAR 2009 MAR 30 28 31 30 Items that are outstanding or received Items that are coming due within the REB approval outside the acceptable next 31 60 days gray or 61 90 days timeframe pink yellow Page 4 of 12 4 Viewing the trial summary and overdue reports screen Individuals coded as EREP CENREP ECRA or PCRA additionally have access to view the trial summary and overdue reports screen To access this screen the user must select the trial summary and overdue reports button after successfully logging in to the utility Ethics Utility Use Location Main Notice Logged in successfully Trial Code Centre 7
3. Most Recent REB Approval Dates Protocol Version Date 2009 FEB 13 Current Consent Version Date English 2009 4PR 07 Current Consent Version Date FrenchvOther Current Tissue Banking Consent Date English 2007 5EP 07 Current Tissue Banking Consent Date French Other If your centre received REB approval for a newer consent form version please send a copy of that consent form and the REB approval documentation in to central office as soon as possible We will update the utility accordingly Please note You must use the most recent REB approved consent form when consenting patients to the study even if this version is not indicated in the utility D I have sent an approval in to NCIC CTG but I do not see it in the utility There are a few possible reasons for this but the most likely cause is either a The item received insufficient level of REB approval Approvals are not entered into the utility if an insufficient level of approval is received For example if an annual re approval required full board approval but only expedited approval was granted the AR will not be entered into the utility b We are in the process of reviewing the approval documentation If you have not heard back within 1 week of providing the updated documentation please contact the ethics research associate for studies under central ethics review or the study coordinator for studies that are not under central ethics review TF you have any q
4. all incoming documents such as annual re approvals AR centre initiated consent form updates CO and initial approval IN For amendments Page 8 of 12 AM AC administrative updates AU AUC and NCIC CTG initiated consent form updates CO this date will be the date that notification email is sent to centres Expiration Date This field applies only to the IN AR documentation The approval is considered expired as of 11 59 59 pm on the date indicated In certain cases amendments may be posted to the NCIC CTG website before NCIC CTG receives the Health Canada NOL to facilitate preparation for REB submission In this situation the date sent to centres will be the date centres are informed that the Health Canada NOL has been received Page 9 of 12 6 Troubleshooting A I can t figure out which entry goes with which amendment in the utility If you are looking for a specific amendment and you can t determine if it is an AM AC AU or AUC please refer to the Letter to Investigators distributed with that amendment For studies that we lead the Doc Type indicated in the utility will match what is in the letter to investigators 1 e if the letter to investigators refers to it as an amendment it will be either an AM or AC if the letter calls it an administrative update it will be AU or AUC etc For intergroup led studies this may not be the case Regardless of who leads the stu
5. for annual re approvals Initial Approval IN For the initial approval the reference number will always be 1 May be incoming 1 for older trials The reference date will be the version date of the protocol that was reviewed For intergroup studies the naming convention on the letter to investigators will be that used by the lead group and may not be the same as is used in NCIC CTG led studies In general what we refer to as an amendment may be referred to by the lead group as an addendum Similarly our administrative updates may be referred to as revisions or updates In the utility the lead group name will be translated into our standard codes of AM AC AU or AUC Page 7 of 12 Date Document Due 1 2 3 Initial Approval IN Annual Re approval AR there will be no due date for these documents Centre initiated Consent Form Updates CO there will be no due date for these documents Amendments AM AC Administrative Updates AU AUC NCIC CTG initiated Consent Form Updates CO and Patient Information Letters PI the due date will reflect the timeframe indicated in the letter to investigators Consent Form Version Date The consent form version date will be the version date indicated on the applicable consent form REB approval letter Local REB Approval Date l Initial Approval IN The local REB approval date for the initial approval reflects the da
6. 9 AH 25 a S E E D C ret wora 7 ocra e OO S S O e e a ohg pewa O OO e fe e ea ace poemaro ocas osa OOOO O O ecos ee feo SP Page 10 of 12 B My REB approved a different consent form version for Amendment X than the one indicated in the utility The consent form version indicated for a particular amendment entry will be the consent form version approved by both your local REB and NCIC CTG for a given amendment If your REB approved a consent form version that was determined to be missing information required with the amendment then this consent form version will be entered as a CO The consent form version that is approved by both NCIC CTG and the local REB will be entered as the consent form version for the amendment The REB approval date for the amendment will be the date that the consent containing all required changes was approved therefore it will reflect the REB approval for the latter consent form version For example For amendment AC1 the REB approved the amended protocol and consent form version 2008JANO1 at a full board meeting on 2008JANI5 When this document was reviewed by NCIC CTG it was determined that mandatory information was not included in the consent form The centre revised the consent to add the required information into version 2008FEBO1 which received REB approval on 2008FEB15 The utility will look like this Ethics Utility Yser Location biain Trial Code Centre Search rial
7. Ethics Utility User s Guide Version Date 2010APR14 1 Logging In To log in enter your User ID and Password and click the Log In button Ethics Utility Location Log in Please sign in term sd pasoi OOO OOOO 2 Searching Once logged in you will be able to search for your centre and a specific trial Entre the Trial Code and Centre and click the Search button i Jane Doe ii TE Ethics Utility User GEE Location fain Motice Logged in successtully Trial Code oOo Centre Please search fora centre and tral Page 1 of 12 EREP CENREP ECRA and PCRA The main screen is different for individuals coded as EREP CENREP ECRA or PCRA ona current participants list These individuals will see the following screen Ethics Utility ser A aes Location Main Notice Logged in successfully Trial Code Centre View Trials and Overdue Reports lease search for a centre and trial NCIC CTG naming convention for Trial Codes For all trials except IND there are 2 3 characters followed by the trial number Ex MA27 or REC2 This utility is not case sensitive so it is acceptable to use upper or lower case letters For IND trials please use the letter I followed by the trial number Ex 1165 or 1170 Also please do not use periods in the trial code MA 27 and I 165 are invalid trial codes according to this convention Page 2 of 12 3 Viewing the trial specific ethics utility screen O
8. Information Central Activation Date 2O06 APR 12 Date of Final Initial REB Approwal 2O06 OCT 25 Thal Status Closed Local Activation Date 2006 OEC 08 Closure Date 2008 DEC 04 fost Recent REB Approval Dates Protocol version Date 2007 SEP 27 Cument Come wt ver ba Oat Egle 2005 MAY 30 Mumrent Comet veka Dae Feichoten uimrent Tke Barklg Comment Oat Eigqlkh S007 oCT Ol cament Thee Barklig Comet iat FreichOtien four next Annual Re approval is due 11 59 59 Phi on 2070 MMAY 27 Date English English French Other FrenchOther Local REB Level of Level of Doc Reference Reference Date Sent Document Consent Tissue Banking Consent Tissue Banking Approval Revjew Rewiew tes C re Hype Mumber Bate Due Version Date Consent Date Version Date Consent Oste Date Reg d Rec d IN INCOMING 1 2006 F EB 20 2006 OCT 05 2006 JUN 23 2006 MAY 26 2 _ CoO 2008JAN01 2008JANO1 2008JAN15 Page 11 of 12 C My centre has REB approval for a more recent consent form than the version indicated in the utility The utility indicates the most recent information that we have on file for your centre gt g ic Current consent form a Utility User Wandy Fletcher A o f Ethics Utility version dates on file at Location Main Trial Code REC2 Centre Search NCIC CTG Trial information Central Activation Date 2006 SEP 14 Date of Final Initial REE Approval 2006 JAH 04 Trial Status Open Local Activation Date 2007 JAN 09
9. dy the reference date and or reference number in the letter will match what is in the utility On Letter to Investigators Reference Number 8 Reference Date 2008MAY05 Re NCIC CTG Study CRC 2 NO147 A RANDOMIZED PHASE III TRIAL OF OXALIPLATIN OXAL PLUS 5 FLUOROURACIL 5 FU LEUCOVORIN CF WITH OR WITHOUT CETUXIMABA AFTER CURATIVE RESECTION FOR PATIENTS WITH STAGE I COLON CAI Protocol Update 3 Dated 2008AUG 18 In Utility Reference Number 8 Ethics I Ttility User Mandy Fletcher EELIS Location lain Trial Code Centre earch ma La lasers Reference Date Trial Information P 2008MAY05 Central Activation Date 20043EF 22 Date of Final Initial REB Approsedl 2007 JUH 08 Trial Status Open Local Activatyeti Date 2007 JUL 31 Most Recent REB Approval Dates Protocol Version Date 2008 AUG 18 Current Consent Version Date Enghsh 2008 DEC DA Curreny nsent Version Date FrenclvOther Current Tissue Banking Consent Date Enghsh 2008 8PR 25 Current True Banking Consent Date FrenclOther Your next Annual Re approvalis due 11 59 39 PM on ie Doc Reference Bee English English _ French Other Frenni iher Local REB Level of Level o Date Sent Pine Number Date Co Tesu ag Hau Consent Tissue Hanking Approval Review Review PEGA P Version Date sne tog s nt Date o Date Consent Date Date sat oe 4 OIN INCOMING 1 2005 AUG e ae i eM WLA 22 P2006 NOF 27 Noy a AR NCOMING 2 AS i G 18 200
10. nce the trial is selected the page will display your centre s trial specific ethics utility screen provided your centre has been locally activated to the specific trial you are searching for This utility is for viewing your centre s ethics screen only You will not be able to edit the displayed data The ethics information is divided into three sections Trial Information Trial Information Central Activation Date 2006 JUL 24 Date of Final Initial REB Approval 2007 SEP 05 Trial Status Closed Local Activation Date 2007 SEP 18 Closure Date 2010 FEB 01 Most Recent REB Approval Dates Protocol Version Date 2009 SEP 01 Current Consent Version Date English 2009 DEC 15 Current Consent Version Date French Other Current Tissue Banking Consent Date English 2009 DEC 15 Current Tissue Banking Consent Date French Other Trial Information Central Activation Date The date the trial was centrally activated by NCIC CTG Trial Status States whether a trial 1s open or closed to accrual Date of Final Initial REB Approval The date your centre s REB granted final approval Local Activation Date The date your centre was locally activated by NCIC CTG Most Recent REB Approval Dates This section states the version dates of your centre s current approved protocol and consent form s according to the documentation received at NCIC CTG Annual Re Approvals The second section lists the information pertaining to the initial a
11. pproval and any subsequent annual re approvals received at NCIC CTG This section also indicates the due date for the next annual re approval If the current annual re approval is outstanding the due date will be red If NCIC CTG no longer requires that your centre continue to obtain annual re approvals for the trial it will be reflected here Annual Re Approvals Your next Annual Re approval is due 11 59 59 PM on 2010 OCT 09 oo Doc Reference a English English French Other French Other Local REB Expiration Level of i T Consent Tissue Banking Consent Tissue Banking Approval aa Review Wani Kiain pig Version Date Consent Date Version Date Consent Date Date ce Rec d IN INITIAL 2007 APR 01 20 07 AUG 30 2007 AUG 30 2006 NOV 1 0 2007 NOW 10 FB AR 1 20 07 APR 01 2007 SEP 27 2007 SEP 27 2007 NOV 10 2008 NOV 10 FB AR 2 20 06 MAR 11 2008 OCT 10 2009 OCT 10 FB AR 3 20 06 MAR 11 2009 OCT 09 2010 OCT 09 FB Page 3 of 12 Other Ethics Review Documentation The third section contains the information pertaining to approval of trial modifications at your centre for example amendments administrative updates consent form updates etc This section is colour coded to indicate any items that are coming due or overdue
12. t information letters that are distributed by NCIC CTG for local REB approval are referred to as PP Initial Approval IN Refers to the initial local approval of the protocol and consent form s Annual Re approval AR refers to the continuing ethics approval for the study Reference Number and Reference Date l Amendments AM AC Administrative Updates AU AUC The reference number for an amendment administrative update will usually match the number of the amendment administrative update as indicated on the letter to investigators For example the reference number for Amendment 1 will be 1 The reference date will be the version date of the protocol Consent Form Updates CO Patient Information Letters PI The reference number for a consent form update patient information letter is sequential For the first CO PI initiated by NCIC CTG the reference number will be NCIC1 If the CO PI is initiated by the centre the reference number of the first will be 1 May be incoming 1 for older trials There is no reference date for consent form updates or patient information letters Annual Re approvals AR The reference number for annual re approvals is sequential For example the first annual re approval will be 1 May be incoming 1 for older trials The number will be ascending according to how many years a centre has participated on a trial There is no reference date
13. te of the full board meeting The date of final expedited approval is listed in the Trial Information section near the top of the screen in the Date of Final Initial REB Approval field Amendments AM AC Administrative Updates AU AUC and Consent Form Updates CO The local REB approval date for amendments and consent form updates will be the date of final approval For example if an amendment requires full board approval and the amendment is conditionally approved at a full board meeting with subsequent final expedited approval this date will reflect the date of final expedited approval Annual Re approval AR The local REB approval date will be the date of the full board meeting or anniversary date when full board approval is required or the date of expedited approval or anniversary date when expedited approval is acceptable Level of Approval Req d Level of Approval Rec d FB Full Board EX Expedited NO Notification EX OK Expedited approval acceptable NO OK Notification acceptable The level of approval req d field is blank for all incoming documents such as annual re approvals AR centre initiated consent form updates CO and initial approval IN For amendments AM AC administrative updates AU AUC and NCIC CTG initiated consent form updates CO the level of approval required will be indicated in the letter to investigators Date Sent to Centres This is blank for
14. uestions or concerns about the information entered in the Ethics Utility please contact the Ethics Research Associate for your centre Page 12 of 12
15. xX ALC1 Next Annual Re approval is due 11 59 59 PM on 2010 SEP 23 Doc Reference Reference Date Sent Type Number Date to Centres AM REVISION 6 2008 MAY 01 2008 MAY 30 2008 AUG 28 EX Level of Local REB Date Due Review Req d Approval Date Page 6 of 12 5 Interpretation Doc Type l 6 Amendments AM AC Revisions that involve substantial changes to the protocol only are referred to as amendments or AM Amendments that involve an updated trial sample consent form will include a C in the naming convention AC For example if the letter to investigators refers to amendment 1 the documentation type will either be AM protocol changes only or AC protocol and trial sample consent form changes Administrative Updates AU AUC Revisions that only involve minor protocol changes are referred to as administrative updates or AU Administrative updates that involve an updated trial sample consent form will include a C in the naming convention AUC For example if the letter to investigators refers to administrative update 1 the documentation type will either be AU protocol changes only or AUC protocol and trial sample consent form changes Consent Form Updates CO Consent form updates only involve revisions to the trial sample consent form or local consent form s These are referred to as CO Patient Information Letters PI Patien
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