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It is the responsibility of the Principal Investigator to inform the Research Office when a study is complete and ready to be closed. The Research Office closes a study if the following two elements are fulfilled [Please note that you must also follow the requirements for the Ethics Committee.]
ALL data collection procedures as per the approved protocol have been completed.
NO further resources are required or utilised on the study.
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:
- post-treatment/intervention contact with research subjects; for example, when data is collected via imaging reports, blood analysis reports, etc. and incorporated into the research study database.
- 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 or review of births and deaths records or hospital records.
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Ministry of Health
