Archiving

Aim

  • The correct archiving of research materials after a study has been completed, enabling repetition of the research or future use of research data

 

Requirements

  • At the end of a study the executing researcher should provide the project leader with all the information required for archiving.
  • At the end of a study the project leader needs to provide the Datamanagement department with data files and documentation (VUMC). For the other organisations, see  below.
  • No confidential, privacy sensitive, information should be stored in the archived data, that is to say, the stored information should not be traceable to individual people, unless study participants have given explicit permission for this. Informed consent forms are allowed in the archive, after removal of the study number. Consent forms must be destroyed after 5 years.
  • The storage of key files according to the different law and regulations (see below).
  • The standard storage period for the electronic data is 15 years. Research performed under the remit of Good Clinical Practice are obliged to store all data and materials for a period of 15 year.

 

Documentation

See requirements

 

Responsibilities

Executing researcher: Should provide documents required for archiving
Project leaders: Ultimately responsible for correct archiving of the project*
Research assistant: Should provide documents required for archiving
* For longitudinal projects (with the exception of large longitudinal studies, such as LASA, Hoorn and AGGO) the project leader and executing researchers are jointly responsible for archiving extensive documentation to enable new researchers to continue the project.

 

How To

What should be archived:
  • logbooks of the analyses;
  • raw data in digital format (at least 10 years according to the Code of Conduct for Scientific Research; a new Code will be published in October 2018);
  • one folder per (published) paper with: 1) final version of paper, 2) final dataset, 3) final syntax;
  • relevant e-mail correspondence; This is easily achieved in Outlook by creating a separate personal file;
  • WMO and WMO-GCP studies have to follow the archiving regulations that are obligatory for WMO and WMO-GCP studies.
  • all other documentation that is relevant to reproduce your results.
    Other documentation, and the electronic version of articles/reports should be handed over to the project leader. Don’t forget to also archive relevant e-mail correspondence. The department Datamanagement & Systeembeheer (Contact person : Wim Kraan) can be provided with the following documents: Cleaned SPSS files (or data files of other analysis programs) at a form-level (i.e. raw data), Input screen, Empty set of questionnaires and registration forms, participant information, consent forms, Research protocol, Code books, Well-documented syntax files for all published tables. All documentation must be in a digital format.
    For AMC researchers, more information about archiving can be found here
    For VU researchers, more information about archiving can be found here
Key Files
A key file is a list coupling a code (study number, participant number, etc.) with the name and contact details of the study participant. The storage of key files is subjected to different regulations :
  • For non-WMO studies: The General Data Protection Regulation (GDPR, Algemene Verordening Gegevensbescherming AVG in Dutch) is applicable. Article 5e of the GDPR demands that data must be de-identified as soon as possible. The destruction of the key file is the first step in de-identification. The key file must be destructed as soon as it is expected that the participants do not need to be approached anymore for the aim of the study.
  • WMO studies:
    • GCP studies
      The key file must be kept during the whole storage period of 15 year
    • WMO studies, GCP not applicable
      The key file must be stored during the storage period of 15 year.  As soon as it is expected that the participants not need to be approached for the aim of the study, the digital version of the key file must be destroyed. Only a paper version must be archived (locked cabinet). This is a prevention measure against possible electronic data breach.
Non digital materials that need to be archived: for VUMC employees, VU employees follow VU rules for archiving- see VUnet)
The original (raw) data recorded in a physical form.
Examples:   Questionnaires, analogue tapes, lab results and paper logbooks. If there are electronic versions of the original data, i.e. scanned questionnaires (images), then the paper versions should not be stored in the physical archive.
Storage period in physical archive
The standard storage period is 5 years from the moment the material is stored into the archive*. Longer storage periods will require permission from the APH board. The Scientific Quality Committee and management will advise the board on request. Examples of this would include longitudinal cohort studies and other studies which may be (potentially) followed up.
Packaging (VUmc)
The material to be stored can only be packaged in standard boxes (available from the management). Each box needs to have a standard label attached stating:
  • WC/SQC number (Scientific Quality Committee number);
  • Project leader’s name;
  • OZ number; (cost object number)
  • Date on which the box will be removed from the archive
Management (VUmc)
The following information is recorded for the material to be archived:
  • The project information (title, wc-codes etc);
  • A description of what has been stored;
  • The number of boxes;
  • The contact person for this material;
  • Storage code;
  • The date on which the archived material will be moved from the archive. The contact person will be notified of the specific date on which the material needs to be collected. Any material not collected will be destroyed.
Access (VUmc)
There is only one access key to the archive room. Access is only possible when accompanied by the management. Contact B. Ouchzou for storage and access questions.
* Material from research projects completed outside the Medical Faculty buildings can not be stored in the Faculty building.

 

Appendices/references/links

 

Audit questions

  1. Are any potential logbooks of the analyses, other documentation, and the electronic version of articles/reports in the project leader’s possession?
  2. Have the right materials been delivered to the D&S department for archiving (VUMC)?
  3. Is the guideline for VU employees followed and is this documented to the project leader?
  4. Have the completed questionnaires been stored in the archive room?
  5. Has, if a report of the research results has not been completed in full, all the material relevant to the report been transferred to the project leader or another associated researcher?
  6. Has the documentation for the longitudinal projects been handed over to the right person to enable a continuation of the project?

 

V3.3: 31 Jul 2018: Links updated, AMC links added, GDPR added
V3.2: 17 Oct 2016: Minor text adjustment; link to VU guidelines added
V3.1: 1 April 2016: Minor text adjustments, addition handling key files
V3.0:  19 June2015: Guideline rewritten; revision format
V2.2: 31 Oct 2013: Addition reminder sending report to METc, revised opinion on storage of informed consents
V2.1: 1 Jan 2010: English translation
V2.0:  4 Oct 2007: Name of transfer modified in transfer and archiving. New rules for archiving, storage period from 10 to 5 years
V1.1: 13 Oct 2005: Privacy added