SMART Study Closeout

Washington ICC Meeting

03 June 2007

SMART ‘Closeout Materials’

Closeout Materials located on INSIGHT website -you must login to obtain materials:

– Access INSIGHT website at www.insight-trials.org – Click “Member log-in” and enter assigned User Name

and Password– Click “Studies”– Click “SMART”– Click “Reports”– Select your ICC, SCC, and then your site– Click “Closeout Materials”

SMART ‘Closeout Materials’

– Closeout memo– Closeout Status Verification CRF – Notes on Completing 065-CLO-1– Clinical Profiles (SCC and Site-specific)

– Remaining Visit Window Report (Site-specific)

– Outstanding Specimen Report (Site-specific)

Closeout MemoTimeline

11 July 2007– Last day of study follow-up– Last day for enrollment into Genomics 065H

12 July 2007– First day to complete and submit Closeout Status Verification

CRFs

01 AUG 2007– All ECGs electronically transmitted (or mailed) to EPICARE

13 OCT 2007– All specimens shipped to ABML– Last day for submission of all CRFs to SDMC

31 December 2007– All data queries resolved

Closeout MemoAttachments

“Dear Participant Letter” – requires IRB/IEC approval prior to distribution

– Give to participant at last study visit or through other means

DAIDS memo re: retention of ECG and BIA machines

Study Follow-up Visits

‘Remaining Visit Window Report’– Complete all study visits with windows open

prior to 12 July 2007• Special emphasis on annual visits• Submit completed study CRF or Missed

Visit Report as soon as possible.– Consider participant for enrollment into

SMART Genomics substudy 065H

ECG Data

ECG Data• Carefully review INSIGHT website for missed or

poor quality ECGs• Can conduct an annual ECG until the next

annual visit window opens– Participant completed annual visit, but missed ECG,

and visit window closed: Collect ECG at next visit, transmit it to EPICARE, submit error corrected ECG section of annual CRF

– Poor Quality ECG or Missed Visits : Collect ECG, transmit, and complete “Unconventional ECG form” from Web – do not error correct annual visit CRF

Closeout Status Verification

Closeout Status Verification CRFPurpose

To verify up until and including 11 July 2007:– Event status (AIDS-related Illnesses, Supplemental

Diagnoses, Grade 4 events)– HIV antiretroviral regimen history– Vital Status

Exceptions:– Patients for whom Death Report Form has been

received at SDMC

Can start to complete CRF on 12 July 2007

Closeout Status VerificationProcess

• Closeout Status Verification CRF (065-CLO-1)

• Participant-specific Clinical Profile and patient’s medical chart or records

• Notes on Completing 065-CLO-1

‘Clinical Profile’

Clinical Profile generated daily by SDMC and posted to INSIGHT website as .ZIP files– Lists all received events– Lists all received changes in ART

Check Clinical Profile against each participant’s medical record to ensure all protocol-defined events have been reported

Contact patient or review medical records to verify status as of 11 July 2007

Notes on Completing the Closeout Status Verification CRF 065-CLO-1

Very Important to have Notes on Completing available while completing CRF.

Example 1:

Comparison of Clinical Profile against the patient’s medical record indicates that the SDMC did not receive AIDS-related illness module for Histoplasmosis

Closeout Status VerificationNotes on Completing

If item 2 is marked “No”, follow these instructions:

Report each unreported event by completing an AIDS-Related Illnesses CRF (065-ARI-1) and the associated AIDS-related illness module. More than one unreported event can be reported on the same AIDS-Related Illnesses CRF. On the AIDS-Related Illnesses CRF, record the date of the Closeout Status Verification CRF (“Date Form Completed”) as the “Date of Visit”.

Closeout Status VerificationNotes on Completing

Example 2:

Comparison of Clinical Profile against patient’s medical record indicates that the SDMC did not receive all changes in ART

Closeout Status VerificationNotes on Completing

If item 8 is marked “No”, follow these instructions:To report each unreported change in ART, either complete

a new Antiretroviral Therapy Change CRF (065-ARC-1) if none was completed with the follow-up visit when the change occurred, or error correct the 065-ARC-1 where the change should have been noted. If a new Antiretroviral Therapy Change CRF is completed, record “99” for follow-up visit month or mark the “Death” box, if submitting this CRF with a Death Report Form (065-DRP-1). Remember to complete the “Page Number” boxes and record the date of the Closeout Status Verification CRF (“Date Form Completed”) as the “Date of Visit”.

Closeout Status VerificationNotes on Completing

What was the patient’s vital status on 11 July 2007?

Section A, Items 9 -10: Mark the “Alive” box if the participant is known to be alive on 12 July 2007 or later. Mark the “Dead” box if the participant died on or before 11 July 2007. Mark the “Unknown” box if the date the participant was last known to be alive is before 11 July 2007. The “Unknown” box can only be marked after every effort has been made to locate the participant. If the “Unknown” box is marked, record the last known alive date in Item 10.

Specimen Shipping

“Outstanding Specimen Report” – updated on the web approximately every 2 weeks

It is a good idea to verify the report against the listed “Visit” CRF, i.e. CRF may have been completed in error

All Laboratory specimens must be received by ABML by 13 October 2007- ICCs have developed a shipping plan with their SCC/sites to ensure on-time completion of shipping

SMART ‘Closeout Materials’Review -1

– Closeout memo• Timeline

– Closeout Status Verification CRF (065-CLO-1)• Purpose to verify that all study-defined events and

changes in ART occurring between randomization and up until and including 11 July 2007 have been reported

• Report participants vital status as of 11 July 2007– Clinical Profiles

• Need to use profile while reviewing patient’s medical chart/records and completing 065-CLO-1

SMART ‘Closeout Materials’Review -2

– Notes on Completing 065-CLO-1• Specific instructions on how to report unreported

events, changes in ART, vital status– Remaining Visit Window Report (Site-specific)

• Lists remaining visit windows up until and including 11 July 2007

– Outstanding Specimen Report (Site-specific)• Lists, by PID, outstanding specimens. Check

report against listed CRF and, if necessary, error correct CRF

Data Queries

Address queries promptly

If you don’t understand a query, please contact your SCC/ICC

All queries must be resolved by 31 December 2007

SMART Study Closeout -1

Checklist in development will include:– All Status Verification CRFs completed and

received by SDMC– All data queries resolved– All outstanding specimens received at ABML– All ECGs (electronic or hardcopy) received by

EPICARE– All monitoring issues resolved

SMART Site Closeout - 2

– IRB/EC notified re SMART Study closure– Site has submitted to Protocol Registration

Office through ICC• Completed Pro Reg checklist marked

“deregistration”• IRB/EC letter stating study has been closed out

OR• Letter from IoR PI requesting deregistration from

SMART 065

– Deregistration notice received from Pro Reg

SMART Study Closeout - 3

There will NOT be a common protocol deregistration date for SMART

Sites will deregister through the SCC/ICC when they have completed all closeout requirements