UBC Research Ethics Boards
Guidance Notes for Notification of Study Closure
GUIDANCE NOTES FOR NOTIFICATION OF STUDY CLOSURE
- ARTICLE #1: DETERMINING WHEN A STUDY CAN BE CLOSED
- ARTICLE #2: NOTIFICATION OF STUDY COMPLETION
- ARTICLE #3: REB ACKNOWLEDGEMENT AND WHOM TO CONTACT FOR ASSISTANCE
- ARTICLE #4: HEALTH CANADA DOCUMENT RETENTION REQUIREMENTS
INTRODUCTION
The following guidance notes, are intended to explain the information that must be submitted to the UBC Research Ethics Board (REB) upon completion of a study.
The completion of a study is a change in activity and must be reported to the REB. Although participants will no longer be “at risk”, a final report / notice to the REB allows it to close its files as well as providing information that may be used by the REB in the evaluation and approval of related studies. It is important to inform the REB how data or biological materials collected during the study will be finally disposed of or stored in order to protect privacy and confidentiality.
ARTICLE #1: DETERMINING WHEN A STUDY CAN BE CLOSED
1.1 Studies Involving Direct Human Participation.
A study may be closed only when ALL data collection procedures as per the approved protocol have been completed. Studies that have completed subject recruitment [i.e. closed to accrual] are not considered closed if data related to the subject is still being collected. This type of data collection activity can include the following:
i) post-treatment contact with research subjects; for example, when data is collected via imaging reports, blood analysis reports, etc.and incorporated into the research study database.
ii) indirect collection of data for follow up purposes after treatment with the study intervention is completed; for example, quality of life/late side effects/survival data. As an example, this type of data might be collected by telephone contact with the research subject or via a third party such as a family physician.
If the study is funded or supported by the US Federal Government (NIH, etc.) it cannot be considered closed until all follow up of subjects is final AND there is no further data analysis involving individually identifiable information.
Grant Funded Studies: If a study is grant funded a completion notice should not be submitted to the REB until there is no active grant that requires ethics approval.
1.2 Studies That Do Not Involve Direct Human Participation
Subject to the requirements for US studies, studies that do not involve direct subject participation, for example, secondary use of data, are considered closed when data acquisition is completed.
Subject to the requirements for US studies, studies that involve the analysis of tissue only are considered closed when no more tissue samples are being withdrawn from the tissue bank or acquired from another research group for studies which analyze human tissue.
ARTICLE #2: NOTIFICATION OF STUDY COMPLETION
2.1 Obligations of the Principal Investigator
Confirm that “data/specimen collection is complete”: The principal investigator/designate for any study involving human subjects must affirm that data collection has been completedso that there is no direct or indirect contact with the subject for purposes of collecting data or biological materials related to that individual, or for US funded studies, no further data or specimen analysis involving personally identifiable information. For a study monitored by the NCIC CTG to be considered complete, the Principal Investigator must have been notified by the NCIC CTG.
2.2 Procedure for Notifying the REB of Study Closure
The principal investigator/designate may submit the closure information to the REB using RISe. Please note that there are separate forms for the Behavioural Research Ethics Board and for the Clinical Research Ethics Board(s). The information that must be included in the submission varies for different types of studies and is detailed below.
2.2.1Clinical Trials
(Reference: ICH Good Clinical Practice Guidelines Article 4.13 “Final Report(s) by Investigator”)
Once the study has been completely closed by a sponsor, RISe must be used to notify the REB of the study closure. The submission should include:
- the Principal Investigator’s affirmation that subject data/sample collection is complete;
- total number of research subjects enrolled at the (local) site;
- the number of unanticipated problems, including local reportable serious and unexpected Adverse Events;
- the date of the study monitor’s final visit;
- the final disposition /storage of all research-related study documents/specimens;
- the final disposition of any electronic data (i.e. locked), and;
- any other information required by the study sponsor or the REB.
- The official “close-out letter” from the sponsor, if applicable.
2.2.2All Other Studies Enrolling Subjects
Using RISe, notify the REB thatthe study has been completed. The submission should include:
- the Principal Investigator’s affirmation that subject data/specimen collection is complete;
- total number of research subjects enrolled at the (local) site;
- the arrangements for final storage and disposal of all research-related study documents/specimens, and;
- the arrangements for final storage and disposal of any electronic data (i.e. locked).
2.2.3Studies Using Secondary Sources of Data/Specimens Only
Using RISe, notify the REB that the acquisition of data/specimens is complete.
ARTICLE #3: REB ACKNOWLEDGEMENT OF NOTIFICATION AND WHOM TO CONTACT FOR ASSISTANCE
The REB office will issue an acknowledgement of the closure notice generally within five business days. Once the Acknowledgement has been issued the study will show under the Investigator’s inactive tab in the RISe system. The only activity available to an Investigator subsequent to this is a Request for Acknowledgement, if needed. The study cannot be amended or reactivated.
Questions regarding the preparation of a notification for closure can be directedto:
BC Cancer Agency Research Ethics Board -(604) 877-6284 or email
Providence Health Care Research Ethics Board -(604) 682-2344 ext. 63496 or email
Clinical Research Ethics Board - (604) 875-4111 ext.68917 or email
Behavioural Research Ethics Board - (604) 827-5114 or email
Children & Women’s Health Centre Research Ethics Board – (604) 875-3103 or email
UBC Okanagan Research Ethics Board – (250) 807-8832 or email
ARTICLE #4: HEALTH CANADA DOCUMENT RETENTION AND STORAGE REQUIREMENTS
According to C.05.012 (4) The sponsor shall maintain all records referred to in this Division for a period of 25 years
Health Canada’s Guide 0068 “Guidance for Records Related to Clinical Trials” found at this link:
Health Canada Guidance provides researchers with guidance pertaining to retention and storage requirements of clinical trial documents.
In accordance with the guideline: The starting time to calculate the retention time is the date when a record is created. For example, when an informed consent is signed, the date of the signature by the subject is the starting date. In practice, it may be easier to calculate the starting date for record retention, as the date of completion or termination of the trial.
Researchers converting regulatory documents into an electronic format should ensure that the requirements stated in the Guidance for Records Related to Clinical Trials (Guide-0068) are met.These may be summarized as follows:
Essential documents should be kept for the entire retention period and in their original medium. Transfer of essential documents from their original medium to a secondary medium may be acceptable, preferably at the completion of a trial, and only if:
•the corrections to the original data can be clearly captured in the secondary medium,
•the person that performs the task of transferring from the original to the secondary medium attest (sign and date an attestation), that the secondary documents are true copies of their respective primary documents, and,
•the transfer process has been fully validated. Evidence of validation should be available for inspection.
January 5, 20121