Research Roadmap

Records Retention

There are two types of records associated with research projects: administrative records and research records, including data. The length of time records are retained varies according to a number of factors, such as the type of record and the type of research.

In general, for internal research, the department funding the research or the PI in charge of the project should retain the official copy of administrative records for a period as described after the termination of the project.

Requirements

Following the completion or suspension of a study that is subject to the Medical Research (Human Subjects) Act (WMO), the coordinating PI or a delegate is responsible for archiving all research data (hard copy and electronic). Section 10 of the NFU brochure Kwaliteitsborging mensgebonden onderzoek (Quality assurance for research involving human subjects) provides an overview of the documents that are intended in this regard.

All study documents (e.g. the TMF/ISF, the data file and the patient files) must be retained for a certain period of time after completion of the entire study, according to the applicable legislation and regulations. The minimum retention period starts after the last research action on the last subject and depends on the type of research, based on the NFU guidelines for quality assurance for research involving human subjects.

These retention periods also apply if the study is terminated prematurely without the inclusion of any subjects.

The principal investigator must take measures to prevent the accidental or premature destruction of the documents. Once the study has been concluded, the destruction date can be entered onto the archive label that is attached to the study documentation. This is based on the last research action on the last subject plus the minimum retention period, as indicated above.

In many cases, the files are stored in an archive. If this is done, it is important to bear in mind that all file folders and boxes must be acid-free. All metals (e.g. staples and paperclips) should be removed, as should any plastic display folders. Although these measures may sound exaggerated, archiving is done for a reason. Should it be necessary to reconstruct a study, it is important for all documents to remain legible.

Remember to make a good inventory list when packing the boxes. If documents must be retrieved at a later date, this can easily be done with the help of the list.

After publication/reporting, arrange for the archiving of the study.  Archiving can be done either within or outside of Amsterdam UMC.

The instructions for the local archiving of the hard-copy and digital data is described in the GCT SOP 03 Management and archiving of essential documents.

External archiving is possible at a company that specialises in storage and archiving and that complies with the legal provisions (e.g. the Archive Act, the Medical Treatment Contracts Act, the Guidelines for Good Clinical Practice). Examples include Iron Mountain and Deudekom.

Internal archiving is free of charge, and costs are associated with external archiving (remember to include these costs in the budget when setting up the study).

Note: For multicenter trials the archiving of essential local study documentation is done according to the retention periods specified in the approved study protocol and the local procedures applicable in the participating centers. At the end of the retention period, the sponsor informs the local principal investigator about the end of the retention period.

Retention periods

Administration Records for Grants/Contracts – Awarded

A record of awarded grant or contract. May include Request for Approval of Application for Grant or Contract, Proposal for Grant or Contract, 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 Medical research involving human subjects act (WMO-plichtig onderzoek): as long as the official retention period of the study. For all other kind of research: 5 years after close of study 
• Disposition Method: Shred or Delete
• Reference: MREC; CCMO;

Contracts

Contracts and agreements in general.

• Official Copy: Department, Section or Unit
• Retention: In general 7 years for tax-requirement. For contacts involved with studies: as long as the official retention period of the study.
• Disposition Method: Shred or Delete - in consultation with the 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. 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; 

Declaration of non-WMO research / Certificate of Exemption for Human Subjects Research

Research protocol and application including the declaration of non-WMO research and all communication including the comments received by MREC (for medical research)/ERB (for non-medical research).

Files may include, but are not limited to, the following: master copy of applications, Review Committee's disposition documents, investigator's responses to the Committee, consent forms, sponsor research protocols, correspondence and supporting papers, modifications to applications, annual status reports, and other relevant Compliance Office approvals.

• Official Copy: Principal Investigator
• Retention: 15 years after close of the study 
• Disposition Method: Shred or Delete
• Reference: SOP RDM001

Human tissue bio-bank - Approved

Applications submitted to Biobank Committee and/or MREC for approval to use human tissue bio-bank in research projects. Files may include, but are not limited to, the following: master copy of applications, Review Committee's disposition documents, investigator's responses to the Committee, consent forms, sponsor research protocols, correspondence and supporting papers, modifications to applications, annual status reports, and other relevant Compliance Office approvals.

• Official Copy: Principal Investigator
• Retention: As long as the official retention period of the study.
• Disposition Method: Shred or Delete
• Reference: MREC; CCMO

Human Subjects Research: Consent Forms (Adults)

Records relating to the permission granted by adult subjects to participate in a human subjects research program, or clinical studies/trials.

• Official Copy: Principal Investigator
• Retention: After removal of the study number, for the same duration as main storage requirement for the type of study (nWMO: 5-15 years, WMO: 15-30 years depending on MDR/GCP/ATMP involvement).
• Disposition Method: Shred or Delete - in consultation with the Data Protection Officer
• Reference: MREC; CCMO; GCP-ICH 6

Human Subjects Research: Consent Forms (Minors)

Records relating to the permission granted by parent, legal guardian or other adult, for children under the age of 18 to participate in a human subject research, as well as records of assent by children for participation in human subject research. Includes Human Subjects and/or Clinical Studies/Trials. Note: Minors are defined for specific studies by applicable national, and international laws.

• Official Copy: Principal Investigator
• Retention: After removal of the study number, for the same duration as main storage requirement for the type of study (nWMO: 5-15 years, WMO: 15-30 years depending on MDR/GCP/ATMP involvement).
• Disposition Method: Shred or Delete- in consultation with the Data Protection Officer 
• Reference: MREC; CCMO; GCP-ICH 6

Human Subjects Research: Deliverables

Records or products developed or produced as the result of a research grant or grant agreement. May include: reports, studies, surveys, educational materials, prototypes, publications, videos, recordings, and multi-media materials, etc

• Official Copy: Principal Investigator
• Retention: for the same duration as main storage requirement for the type of study (nWMO: 5-15 years, WMO: 15-30 years).
• Disposition Method: Shred or Delete - in consultation with the Data Protection Officer
• Reference: MREC; CCMO; GCP-ICH 6

Laboratory notebook

A laboratory notebook should be digital. Amsterdam UMC uses the eLABJournal Electronic Lab Notebook (Bio-ITech). Only when there is no digital solution available should research data be recorded in a hard copy official laboratory notebook. Laboratory notebooks should be kept in a safe place and stored for 10 years after the last entry.

• Official Copy: Principal Investigator
• Retention: 10 years after the last entry
• Disposition Method: Shred or Delete
• Reference: Amsterdam UMC research code

Medical devices

Research documentation and raw data obtained in the course of a study. May include Investigators' Notebooks (laboratory notes documenting the results of experiments), patient files, case files, consent forms, and other records of the dates. Research documentation and raw data obtained in the course of a study.

• Official Copy: Principal Investigator
• Retention: 10 years after close of study; MDE that are put on the market: 10 years after approval; Implantable MDE: minimal requirement of 15 years after close of study (to be determined in consultation with the DPO and MDE experts).
• Disposition Method: Transfer to Archives - in consultation with the Data Protection Officer 
• Reference: MDR, XV, H3 - 3; CCMO

Research Data - Drug Development - Advanced therapeutic medicinal products (ATMP)

Advanced therapeutic medicinal products (ATMP) are gene therapy medicinal products; GTMP's, somatic cell therapy medicinal products; sCTMP's and tissue engineered products; TEP's. Research documentation and raw data obtained in the course of a study to develop a drug. May include Investigators' Notebooks for New Drugs (laboratory notes documenting the results of experiments involving new drugs), patient files, case files, consent forms, and other records of the dates, quantity and use of a new drug on subjects.

• Official Copy: Principal Investigator
• Retention: 30 years after close of study
• Disposition Method: Transfer to Archives - in consultation with the Data Protection Officer 
• Reference: MREC; CCMO; GCP-ICH 6

Research Data - Research under GCP (Investigational Medicinal Products)

This involves Drug development or higher risk class MDE involved studies, where a Trial master file, TMF, eTMF, essential documents, is required for GCP inspection. Research documentation and raw data obtained in the course of a study to develop a drug. May include Investigators' Notebooks for New Drugs (laboratory notes documenting the results of experiments involving new drugs), patient files, case files, consent forms, and other records of the dates, quantity and use of a new drug on subjects.

• Official Copy: Principal Investigator
• Retention: 25 years after close of study
• Disposition Method: Transfer to Archives - in consultation with the Data Protection Officer 
• Reference: MREC; CCMO; GCP-ICH 6

Research Data - Medical research involving human subjects act (WMO-plichtig onderzoek - no

Investigational Medicinal Products)

Research documentation and raw data obtained in the course of a study. May include Investigators' Notebooks (laboratory notes documenting the results of experiments), patient files, case files, consent forms, and other records of the dates. Research documentation and raw data obtained in the course of a study.

• Official Copy: Principal Investigator
• Retention: 15 years after close of study
• Disposition Method: Transfer to Archives - in consultation with the Data Protection Officer 
• Reference MREC; CCMO; GCP-ICH 6

Research Data – non-WMO research (nietWMO-plichtig)

Research documentation and raw data obtained in the course of a study. May include Investigators' Notebooks (laboratory notes documenting the results of experiments), patient files, case files, consent forms, and other records of the dates. Research documentation and raw data obtained in the course of a study.

Official Copy: Principal Investigator

Retention: 5-15 years after close of study (to be determined in consultation with the DPO)

Disposition Method: Shred or Delete - in consultation with the Data Protection Officer (DPO)

Reference: SOP RDM001