Aim

• Correct archiving of research material
• Enabling repeat research or future use of research data
• The research data archive is only intended to allow checks on published data or future follow-up research or check.

Description

Good archiving is a necessity once a study has been completed. Archiving enables repeat studies to be conducted and allows other researchers to use the collated data in the future. A careful transfer of the research needs to be undertaken should the researcher leave the study (early). The project leader is responsible for archiving and transfer.
 
At the end of a study the researcher needs to provide the D&S department with the following:
•          Cleaned SPSS system files at a form-level (i.e. raw data);
•          Input screen;
•          Empty set of questionnaires and registration forms, preferably in a digital format;
•          Research protocol;
•          Code books;
•          Well-documented syntax files for all published tables.

Forms for research projects completed outside the Medical Faculty buildings will not be stored centrally, e.g. stored at the hospital. Refer to the research data archive section for the Medical Faculty.

Privacy:
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. E.g.: informed consent forms are not allowed in the archive. Consent forms must be destroyed after completion of the study.

The researcher should provide the project leader with all the information required for archiving. Potential logbooks of the analyses, 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. This is easily achieved in Outlook by creating a separate personal file. Please refer to the Data and System Management (Datamanagement en systeembeheer) website for guidance on creating profiles and a back-up in Outlook.

Even if the research report has not been completed in full (for instance because the researcher has left), it should still be transferred to the project leader or, in consultation with the project leader, to another associated researcher.

For longitudinal projects (with the exception of large longitudinal studies, such as LASA, Hoorn and AGGO) the project leader and researcher are jointly responsible for archiving extensive documentation to enable new researchers to continue the project. For researchers on the LASA study, Hoorn study and AGGO study the documentation needs to be left with Jan Poppelaars, Jacqueline Dekker and Jos Twisk, respectively.

Research data archive
Materials that need to be archived
The original data from completed projects. This exclusively refers to: Questionnaires, analogue tapes, lab results and logbooks. If there are electronic versions on the original data, i.e. scanned questionnaires (images), then the paper versions should not be stored.

Storage period
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 EMGO+ board.
The Quality Committee (kwaliteitscommissie, KC) 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
The material to be stored can only be packaged in standard boxes. Each boxes needs to have a standard label attached stating:
•          SC number (Scientific Committee number);
•          Project leader’s name;
•          OZ number; (cost object number)
•          Date on which the box will be removed from the archive
Boxes and labels are available from the management.

Management
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
There is only one access key to the archive room. Access is only possible when accompanied by the management.

Future
Given that it is anticipated that there will be little or no archive space available in the a new building, archive space will be scarcer than it currently already is. Efforts are being made to store as much as possible in an electronic format and only to physically store that material which is strictly necessary.

Background to storage period
There are no statutory obligations regarding the storage of research data, with exception of drug trials. These fall under Good Clinical Practice. If there are no statutory guidelines, we reviewed the storage periods that are employed at various establishments:

The Netherlands:
COREON, (COmmissie REgelgeving ONderzoek van de Federatie Medische Wetenschappelijke Verenigingen, Regulatory Committee for Research of the Federation of Medical Scientific Association, FMWV) stipulates a period of 5 years as good practice. This code has been subscribed to by every member, including the Epidemiology Association.

At NIVEL in Utrecht materials are stored for 5 years as standard, after which material is reviewed to determine whether it can be destroyed. Their experience is that nobody needs the material after five years. Paper questionnaires are destroyed once the questionnaires have been scanned and back-ups have been made.

At IMG in Rotterdam a 5 year storage period is place, unless the projects are to be (potentially) followed up. Paper questionnaires are destroyed once the questionnaires have been scanned and back-ups have been made.

At the RIVM in Bilthoven questionnaires are stored permanently. Other material is stored between 5 and 10 years. The organisation does not have any problems with archive space, which is still underused. However, the expectation is that the storage period will be shortened as the archives become fuller. Once the documents have been scanned, the paper versions are destroyed.

Abroad:
Guidelines for Good Epidemiology Practices for Drug, Device, and Vaccine Research in the United States 1996: 5 years
Michigan State University: A minimum of 3 years, unless there are reasons for storing material longer.
University of Melbourne: Stored until 5 years after the last publication.

The Lancet: At any time up to 5 years after publication of research in the journal, authors may be asked to provide the raw data.

Conclusion
A storage period of 5 years is very common. Five years is also the period usually stipulated in contracts, for instance, with businesses, which is why a 5 year storage period has been chosen.

• Please consult the guideline “dealing privacy sensitive data” for confidential data or ask the Privacy officer of the institute.

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.
V1.0: 17 Aug 2005: Archiving e-mail correspondence added.

1)         Have the right materials been delivered to the D&S department for archiving?
2)         Have the completed questionnaires been stored in the archive room?
3)         Are any potential logbooks of the analyses, other documentation, and the electronic version of articles/reports in the project leader’s possession?
4)         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?
5)         Has the documentation for the longitudinal projects been handed over to the right person to enable a continuation of the project?