Research Roadmap

Records Retention

Research involves two types of records: administrative records and research records, including data. The retention time of these records depends on various factors, such as the type of record and the type of research.

In general, for Amsterdam UMC research, the department initiating the study or the principal investigator (PI) in charge of the study is responsible for retaining the official copy of administrative records for a specified period after termination of the study.

The coördinating PI or a delegate is responsible for archiving all research data (hard copy and electronic) after termination or suspension of the study. Chapter 10 of the UMCNL Guideline Quality Assurance Research involving Human Subjects provides an overview of the applicable documentation for research subject to the WMO.

All study documentation - including the Trial Master File (TMF), Investigator Site File (ISF), data files, and patient files - must be retained for a period defined by applicable laws and regulations. The retention period starts after the study's official end date (i.e. the date the last participant underwent the last study procedure), with (minimum) durations depending on the type of reseach, as stated in the UMCNL Guideline. These retention periods also apply if the study is terminated prematurely without enrolling participants.

For multicenter studies, local study documentation must be archived according to the retention period specified in the approved research protocol and the local procedures at the participating centers. At the end of the retention period, the sponsor must notify the local PI.

Requirements

The PI must take measures to prevent that study documentation is destroyed accidentally or prematurely. The destruction date of the documentation should be noted on the archive label, which should reflect the study's end date plus the (minimum) retention period.

When storing documents in an archive, ensure that all file folders and boxes are acid-free, and remove all metals (e.g., staples and paperclips) and plastic display folders. While these measures may seem excessive, they are important to preserve legibility in case a study needs to be reconstructed.

Maintain an inventory list of the archived folders and boxes for easy retrieval of documents if needed.

After publication, arrange for long-term archiving of the study documentation, either within or outside Amsterdam UMC. Procedures for archiving within Amsterdam UMC (both hard copy and digital data) are described in GCT SOP 03 Management and archiving of essential documents.
External archiving can be arranged with a specialized company that complies with relevant legal requirements (e.g. Archives Act, Dutch Medical Treatment Contracts Act (WGBO) and GCP-guidelines). Examples are Iron Mountain and Deudekom.
Archiving within Amsterdam UMC is free of charge, while exernal archiving incurs costs. Remember to account for these costs in the study budget during the preparation phase.

Retention periods

Administration Records for Grants/Contracts – Awarded

Records related to awarded grants or contracts. This may include: requests for approval, proposals, award letter/notice, agreements (including supplements or amendments), notice to establish account, correspondence, final equipment inventory, project/planning files, etc.

• Official Copy: Department, section or unit
• Retention: For research subject to the WMO/CTR/MDR/IVDR: until the study's official retention period ends. For all other research: 5 years after the study's end date
• Disposition Method: Shred or delete
• Reference: MREC, CCMO

Contracts

Contracts and agreements in general.

• Official Copy: Department, section or unit
• Retention: Generally 7 years for tax purposes. For study-related contracts: until the study's official retention period ends
• Disposition Method: Shred or delete (in consultation with Legal Counsel)
• Reference: Belastingdienst

Data Entry Form

Provides a record of information collected via a form, log, or electronic submission that is used for data entry into a database or spreadsheet. This may include: financial data, research data, employee information, survey responses, questionnaires, student information, etc.

• Retention: Data entered and verified
• Disposition Method: Shred or delete
• Reference: RDM, Privacy, GDP

Non-WMO declaration / Certificate of Exemption for Research involving Human Subjects

The application file, as well as the declaration/certificate and all communications with the non-WMO Review Committee (for medical-scientific research) or ERB (for non-medical scientific research).
This may include: master copy of application file, review committee's disposition documents, investigator's responses to the committee's comments, informed consent forms, research protocols, correspondence and supporting papers, modifications to application, annual progress reports, other relevant compliance office approvals, etc.

• Official Copy: Principal investigator
• Retention: 5-15 years after the study's end date
• Disposition Method: Shred or delete
• Reference: SOP RDM001

Biobank approval

Applications submitted to the Amsterdam UMC Biobank Review Committee (Commissie Toetsing Biobanken) for approval to set-up a biobank or to conduct research with material from an existing biobank.
This may include: master copy of application file, review committee's disposition documents, investigator's responses to the committee's comments, informed consent forms, research protocols, correspondence and supporting papers, modifications to application, annual progress reports, other relevant compliance office approvals, etc.

• Official Copy: Principal investigator
• Retention: Until the study's official retention period ends
• Disposition Method: Shred or delete
• Reference: CTB

|nformed Consent Forms

Records of the permission granted by an adult to participate in medical-scientific research, records of the permission granted by parents or legal guardians for children under the age of 16 to participate in medical-scientific research, or records of assent from children themselves for participation in medical-scientific research.

• Official Copy: Principal investigator
• Retention: After removal of the study number, until the study's official retention period ends (WMO/CTR/MDR/IVDR: 15-30 years and non-WMO: 5-15 years after the study's end date)
• Disposition Method: Shred or delete (in consultation with the Data Protection Officer (DPO))
• Reference: MREC, CCMO, ICH-GCP

Deliverables

Records of products developed or produced as a result of a research grant or grant agreement. This may include: reports, studies, surveys, educational materials, prototypes, publications, videos, recordings, multimedia materials, etc

• Official Copy: Principal investigator
• Retention: until the study's official retention period ends (WMO/CTR/MDR/IVDR: 15-30 years and non-WMO: 5-15 years after the study's end date)
• Disposition Method: Shred or delete (in consultation with the DPO)
• Reference: MREC, CCMO, ICH-GCP

Laboratory notebook

Amsterdam UMC uses the eLABJournal (Bio-ITech) for electronic lab notebooks. Only when no digital solution is available should research data be recorded in a hard copy laboratory notebook.

• Official Copy: Principal investigator
• Retention: 10 years after the last entry
• Disposition Method: Shred or delete
• Reference: Amsterdam UMC Research Code

Research Data - Research involving medical devices

Research documentation and raw data obtained in the course of a study. This may include: researchers' notebooks (f.e. laboratory notes documenting the results of experiments), patient files, case files, informed consent forms, other records of the dates, quantity and use of a new device on participants, etc.

• Official Copy: Principal investigator
• Retention: 10 years after the study's end date; medical devices for market approval: 10 years after approval; implantable medical devices: minimum 15 years after the study's end date (to be determined in consultation with the DPO and medical device experts)
• Disposition Method: Transfer to archives (in consultation with the DPO)
• Reference: MDR, XV, H3 - 3, CCMO

Research Data - Advanced therapeutic medicinal products (ATMP)

Research documentation and raw data obtained in the course of a study involving gene therapy, somatic cell therapy, or tissue-engineered products. This may include: researchers' notebooks (laboratory notes documenting the results of experiments), patient files, case files, informed consent forms, other records of the dates, quantity and use of a new drug on participants, etc.

• Official Copy: Principal investigator
• Retention: 30 years after the study's end date
• Disposition Method: Transfer to archives (in consultation with the DPO) 
• Reference: MREC, CCMO, ICH-GCP

Research Data - Research involving medicinal products

Research documentation and raw data obtained in the course of a study. May include: researchers' notebooks (laboratory notes documenting the results of experiments), patient files, case files, informed consent forms, other records of the dates, quantity and use of a new drug on participants, etc.

• Official Copy: Principal investigator
• Retention: 25 years after the study's end date
• Disposition Method: Transfer to archives (in consultation with the DPO)
• Reference: MREC, CCMO, ICH-GCP

Research Data - Other research subject to the WMO

Research documentation and raw data obtained in the course of a study. May include: researchers' notebooks (laboratory notes documenting the results of experiments), patient files, case files, informed consent forms, etc.

• Official Copy: Principal investigator
• Retention: 15 years after the study's end date
• Disposition Method: Transfer to archives (in consultation with the DPO)
• Reference MREC, CCMO, ICH-GCP

Research Data – non-WMO research

Research documentation and raw data obtained in the course of a study. May include: researchers' notebooks (laboratory notes documenting the results of experiments), patient files, case files, informed consent forms, etc.

• Official Copy: Principal investigator
• Retention: 5-15 years after the study's end date (to be determined in consultation with the DPO)
• Disposition Method: Shred or delete (in consultation with the DPO)
• Reference: SOP RDM001