Central Adelaide Local Health Network - Research Office
Clinical Trial Document Submission and Reporting Guideline
CALHN (RAH or TQEH/LMH/MH)HREC as Reviewing HREC (i.e. your site is the lead site)
Please submit documents to the reviewing HREC and/or CALHN Research Officeemail: d/or
A response will be given on behalf of the reviewing HREC and CALHN Research Office.For multi-centre studies the response email must then be sent to all other participating sites.
Please Note:1. This guideline is to be used to direct submission of necessary documents for clinical trials that have previous HREC and Governance approval through RAH or TQEH/LHM/MH HRECs.
2. For initial submissions, refer to the CALHN ‘Full Site Specific Assessment Form Checklist” document, found at: the “Clinical Trials” tab.
3. CALHN HREC refers to the RAH REC and TQEH/LMH/MH HREC
Send the following to HREC/ Email to CALHN
HREC / from HREC Chair/CALHN Research Office / Additional information: Reviewing HREC is either RAH HREC or TQEH/LMH/MH HREC
If the study is conducted under national mutual acceptance (NMA) the email from the reviewing HREC needs to be sent to all other the participating Research Offices but not to CALHN Research Office
Amendment / Send as soon as possible
Protocol amendments / Yes (PI) / Approval email / Email the tracked version of the amended protocol
Provide a summary of changes including the rationale for each amendment including any impact on the CTRA
Amendments to other trial documents / Yes (PI) / Approval email / Email tracked changes to questionnaires, advertisements, instructional information to participants
PICF / Send as soon as possible
Amended Multi-centre master PICF / Yes (PI) / Approval email / Require both tracked and clean versions and an explanation of the need for the change.
With version control. Accompanies the CALHN site specific PICF
Amended RAH /TQEHsite PICF / Yes (PI) / Approval email / Require both tracked and clean versions and an explanation of the need for the change.
Safety / Note: all communication from Sponsor to HREC must CC the PI
Investigator Brochure- amendment / Yes (Sponsor) / Acknowledgement email / Sponsor to email a version containing a Summary of Changes, CC’ing PI. Updated PICF should be submitted at the same time. IB must be reviewed and acknowledged by PI. Provide information which may impact on participants’ safety.
SAEnot related to investigational product or device / No / N/A / Send report to Sponsor within 24 hours of becoming aware of the event or as specified in the protocol.
SAR/SADE – related to investigational product or device but expected / No / N/A / Send report to Sponsor within 24 hours of becoming aware of the event or as specified in the protocol.
SAE/SUSAR/USADE/SAR– related to investigational product or device and unexpected / Yes (Sponsor) / Acknowledgement email / Send report and supporting information to Sponsor (24 hours) of becoming aware of the event. Sponsor to send to CALHN HREC (72 hours), CC’ing PI. HREC acknowledges on behalf of CALHN HREC and RGO. Sponsor to report to TGA as per NHMRC Guidance.
Urgent safety measures / Yes (Sponsor) / Approval email / Any measure required to be taken to eliminate immediate hazard to participant health/safety. Send to Sponsor. Sponsor to send to HREC, CC’ing PI.HREC acknowledges on behalf of CALHN HREC and RGO.
External SUSAR/USADEs. Line listings and safety reports, SUSAR/USADE Industry or DSMB reports/letters to be included / No / N/A / Sponsor may notify site however PI is not required to print, review or file but will acknowledge receipt.Sponsor to include in annual safety report.
Protocol deviation /violations –only those that impact immediately on the safety of the participant / Yes (Sponsor) / Acknowledgment email / Send to report to Sponsor (within 24 hours). Sponsor to send to CALHN HREC(within 72 hours), CC’ing PI.
Annual safety report / Yes (Sponsor) / Acknowledgement email / Sponsor to submit to HREC, CC’ing PI. Include: Line listings and safety reports, SUSAR/USADE Industry or DSMB, DSUR reports/letters to be included.
Reports
Commencement of trial / Yes (PI) / Acknowledgement email / Email notification
Annual Reports / Yes (PI) / Acknowledgement email / Email report from approval date until study closure
Study or Site closure / Yes (PI) / Acknowledgement email / Email notification within 14 days
Final Report / Yes (PI) / Acknowledgement email / Email report within 30 calendar days of study completion
Other
General correspondence – material impact / Yes (PI) / Acknowledgement/Approval email / Memos that impact on the study. Clarification of inclusion /exclusion criteria.
General correspondence – no material impact / No / N/A / Change to CRFs. Study recruitment closure. Participant withdrawal
Change in banking details or Sponsor’s address / Yes (PI) / Acknowledgement/Approval email / Email letter from Sponsor indicating change
Change in Principal Investigator / Yes (PI) / Acknowledgement/Approval email / Email details and acknowledgement from Clinical Director as soon as possible
Increase in enrolment number / Yes (PI) / Acknowledgement/Approval email / Email letter from Sponsor indicating approval for change as soon as possible
Complaints / Yes (PI) / Acknowledgement/Approval email / Within 72 hours report of any complaints received by an investigator of a study participant
Send The Following To CALHN Research Office: / CALHN
Research Ethics / CALHN Research Office
Legal
CTRA Amendment / No / Signed amendment agreement / Require HREC approval letter where applicable e.g. change to protocol affecting budget; change of PI;
HREC review only Form of Indemnity amendment / No / Signed Indemnity
Site specific Standard Form of Indemnity amendment / No / Signed Indemnity Agreement / Require current insurance certificate
Updated Insurance certificate / No / Acknowledgement
Clinical Trial Document Submission and Reporting Guideline CALHN HREC 5 April 2017 Page 1 of 2