Research Roadmap

Research subject tot the WMO

All study documentation - including the Trial Master File (TMF), Investigator Site File (ISF), study specific data and patient files - must be retained for a period defined by applicable laws and regulations. This retention period is necessary to allow for verification by government agencies, sponsors, or journals. Consequently, the research file to be archived must contain sufficient information to make it possible to fully reconstruct the study afterward. 

The retention period starts after the study's end date (i.e. the date the last participant underwent the last study procedure). (Minimum) durations vary based on the type of reseach, as stated in GCT SOP 03 Management and archiving of essential documents, and apply even if the study is terminated prematurely without enrolling participants.

The (coördinating) principal investigator (PI) is ultimately responsible for ensuring that the official copy of all study documentation (both hard copy and digital elements) is archived in compliance with the legally applicable retention periods.

Ïn case of multicenter studies, the (coordinating) PI is responsible for both informing the local PIs that the local study documentation must be archived according to the retention period specified in the approved research protocol, and for notifying them at the end of the retention period. Local procedures at the participating centers can be taken into account.

Procedures for archiving within Amsterdam UMC (both hard copy and digital data) are described in GCT SOP 03 Management and archiving of essential documents. You will also find the various application forms here.

Research NOT subject to the WMO 

For research that is not subject to the WMO, there are no specific statutory retention period. Instead, the considerations set out in the Code of Conduct for Health Research serve as the primary basis for determining an appropriate retention period.

For any study involving the processing of (directly or indirectly identifiable) personal data, the General Data Protection Regulation (GDPR) requires that a data retention period be established. This period should be justified, for example in the study protocol or data management plan, and participants must be informed about it.

The retention period for data and human biological material used in scientific research is not always clearly defined in legislation and regulations. Under Article 5(1)(e) of the GDPR, personal data and human biological material may not be retained for longer than is necessary for the purpose for which they were collected. Several factors should be considered when determining an appropriate retention period. Section 8.2 of the Code of Conduct for Health Research provides an overview of the most important considerations. These include statutory retention requirements, institutional policies, opportunities for replication and validation, and the need to retain data and materials for future scientific research.

Where no statutory retention obligation exists and/or it is not known in advance how long the data and materials will be needed, it is also possible to specify that periodic evaluations will be conducted to determine whether continued retention remains necessary or appropriate. This approach is particularly relevant for research infrastructures such as biobanks and registries. The National Guidance on the Evaluation of Biobank Collections can be a useful resource in this context. This guidance provides comprehensive recommendations and considerations to support well-informed decisions on whether to retain, transfer, or discontinue a biobank collection. It also includes an assessment of whether the biological material remains suitable for its intended purpose, in this case scientific research.