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, the standard storage period is 5 years after the closure of the study (APH policy). This may vary per type of research and should in general be kept 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).

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.

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: METc; CCMO; APH policy – See Archiving
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
Conflict of Interest Files (COI)

Provides a record of University/UMC efforts to manage, reduce, or eliminate Financial Conflicts of Interest between Investigators and Innovators and Companies, or other external organizations who fund research, collaborate on research, or for which Investigators have a Significant Financial Interest which may include providing outside professional services. Records for sponsored research are initiated at time of proposal, records for internal research and technology transfer are initiated by first disclosure or request to review by researcher or other administrative unit. Files are established when an employee with the designated role of Investigator involved in research, or Innovator for technology transfer has a Financial Conflict of Interest between outside interests or activities and research, sponsored program, or technology transfer occurring at the University/UMC.

  • Official Copy: Department and Principal Investigator
  • Retention: 5 years after close of study
  • Disposition Method: Shred or Delete
  • Reference: APH policy – See Archiving
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.

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 METc (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; Archiving
Human tissue bio-bank - Approved

Applications submitted to Biobank Committee and/or METc 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: METc; 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: METc; 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: METc; 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: Transfer to Archives or, Shred or Delete - in consultation with the Data Protection Officer
  • Reference: METc; 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: METc; 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: METc; 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 METc; 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

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