Annual Progress Report/ Final Report Form
- Annual reports are due every year on the anniversary of the date the study was approved and until the study is completed.
- The report must be submitted in hard copy and signed by the Principal Investigator unless it is emailed to the Research Co-ordinator’s office
- FINAL STUDY REPORTS, complete Final Report Section
- Final reports are submitted when the study is closed and completed at all study sites unless no participants were enrolled at a site.
- A cover letter is not required with this report form.
Protocol title:
Protocol number:
CHCA HREC Reference No:
Principal Investigator:
PROGRESS SUMMARY
Status of the project
If the project has been completed, terminated or abandoned, please complete the Final Report section
Project commenced
Is the Project ongoing?
If yes, what is the estimated completion date:
Has the Project completed?
If yes, enter the completion date:
Was the project:
[provide a reason if not yet commenced, prematurely terminated or abandoned] / ____ / ____ / ______
Y N
____ / ____ / ______
YN
____ / ____ / ______
Prematurely terminated Abandoned Not commenced
______
Have you received interim results from the project?
If Yes, please attach details / Yes No
Participant recruitment
Number of participants consented to date?
Have there been delays in recruitment?
[If yes, provide details]
Has recruitment been completed? Has participant involvement completed? / ______
Y N
______
YN
Y N
Number of participants withdrawn from study?
[Please provide numbers and reasons for withdrawal] / No:______
Reasons: ______
______
______
______
RESEARCH CONDUCT
Is the project being conducted in compliance with the approved protocol?
Current protocol version being used: / Y N [attach list of any protocol deviations/violations]
______
Amendments
Have there been any amendments to the project in the last 12 months? / Y N
If Yes, please list below [amendment number, date and date approved by HREC]
Amend No: ______Date: ___ / ___ / ____ Date approved: ___ / ___ / _____
Participant Information Sheet and Consent Forms (PIS&CFs)
Please list the most recent version/s used: [Version number, date and date approved by HREC] / Version No: ______Date: ___ / ___ / ____ Date approved: ___ / ___ / _____
Serious Adverse Events (SAEs), including SUSARs
Have there been any SAEs, including SUSARs, or significant events that impact on the study in the last 12 months?
If Yes, have you informed the HREC Executive Committee of these events? / Y N If No, skip the next question
Y
N [If No, please forward to the HREC]
Line listings of SAEs and SUSARs [tick if not applicable ] For sponsored studies only
Have line listings been received from the sponsor at least 6-monthly?
If Yes, has the PI reviewed all listings and reported anything of significance to the HREC? / YN If no, Please provide details ______
Y, reviewed but nothing to report
Y, reviewed and reported
Issues of ethical significance
Have findings of ethical significance arisen at this site or elsewhere? / NPlease go to next question
YPlease attach details
Data Safety and Monitoring Board (DSMB) [tick if no DSMB
Have all DSMB outcomes been provided to the HREC? / Y
N If No, submit any outstanding reports to the HREC
Registration [tick if not applicable
Has the trial been registered with a WHO-accredited clinical trials registry? / Y Name of registry and registration number:
______
N Please explain why not:
______
Audit
Has the project been audited? / Y Please attach report
N
Insurance [tick if not applicable ]
Is the insurance certificate current? / Y
NPlease obtain a current copy from the sponsor and forward to the HREC as soon as possible.
Compensation
Have any compensation payments (damages) been awarded to any participants as a result of their participation in this study? / YPlease provide details:
______
N
Privacy and Confidentiality of Data / My signature confirms that data is maintained securely and is only accessible to authorised study personnel.
FINAL REPORT / Not applicable
Project completion date / ____ / ____ / ______
Lay summary of findings / (please attach abbreviated clinical study report as per ICH GCP)
Total number of participants recruited at CHCA sites / ______
Details of publications or accepted or in press. / No [please explain why]
______
______
Details of any presentations given / Please attach
Have study participants been informed of the results?
Please give details. / Y N Not applicable
______
______
Have participants been informed which treatment they received? / Y N Not applicable
Archiving Period
15 years Interventional/Clinical research (drugs, devices, medical tmts) / 5 years Non Interventional / Low Risk projects / 12 months Short term/Student projects / 3 years Other (E.g. Project never commenced, projects not approved, no pts enrolled)
DECLARATION
I confirm that this project has been conducted as originally approved by Calvary Health Care Adelaide Human Research Ethics Committee (and subject to any changes subsequently approved as amendments).
I confirm that this project continues to be conducted in compliance with the NHMRC National Statement on Ethical Conduct in Human Research (NHMRC, 2007).
I confirm that this report accurately reflects the progress of the project.
_____ / _____ / ______
Date Name of Principal Investigator
______Signature of Principal Investigator
Original to be sent to:
CHCA HREC CHAIR
Calvary SA HREC Office
Care of 300 Wakefield St
Adelaide SA 5000
Or by email to the Research Co-ordinator
A Copy is to be kept by Investigator
HREC comment:
Reviewed and acknowledged
Signature of HREC Executive Officer/Delegate: ______
Date: ____ / ____ / ______
Notes
The researcher shall provide to the committee an Annual Review or Report of the study occurring at this site. Annual reports are reviewed by the Chairperson of HREC and filed with study documentation.
The report shall contain the following information:
- Study Identification
- Principal Investigator identification
- Current Status of the Project (Complete/In Progress/Ceased/Not commenced)
- The occurrence of serious adverse events at this site
- The number of participants entered into the trial
- The number of participants withdrawn from the trial
- A brief description of the progress of the trial
Final study closure: At the conclusion of a trial the researcher must notify the HREC of the site closure using the Final Report form or similar.
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