Research Projects Archiving

Head of Clinical Research Service

Geneviève Filion

+1 418-525-4444, ext. 48545

genevieve.filion@crchudequebec.ulaval.ca

Directive: Closure of a Clinical Research Project (Archiving)

Mary-Ann Desrosiers, Administrative Assistant – Research document management and archiving

+1 418-525-4444, ext. 46150

directive.archivage@crchudequebec.ulaval.ca

Please note: for all matters relating to medical archives (medical records), please contact the Medical Archives team at the following address: archivesrecherche@chudequebec.ca.

The CHU de Québec-Université Laval Research Centre Management (DCRCHU, for Direction du Centre de recherche du CHU de Québec-Université Laval) offers a secure electronic archiving environment, administered by the Clinical and Evaluative Research Platform (PRCE, for Plateforme de recherche clinique et évaluative).

The PRCE offers its customers a high-quality electronic archiving service, conducted in its up-to-date digitization stations, in compliance with an internal validation process. PRCE conducts its role and responsibilities in such a way as to provide an efficient service and simplified application logistics for the parties involved. The document digitization process is also entirely managed and conducted by the PRCE.

It is the responsibility of the principal investigator or investigator-in-charge, the sponsor, and the team whose project has been authorized at the institution to be aware of the procedures for archiving the project. To this end, the storage of trial documents must be planned from the start of the study by the partner or the sponsor researcher, to ensure that the financial and human resources are available and planned for, and to comply with regulatory requirements.

It is the responsibility of the clinical trial principal investigator and his/her team to prepare the documents to be archived so that they are legible, intact, and complete, and to ensure that the originals to be retained are retained. In addition, they must ensure that the documentation given to the PRCE team is first purged and prepared in accordance with the good practices detailed in the following document.

The Principal Investigator is also responsible for the costs associated with the electronic archiving of his/her clinical research project documents, where applicable.

Administrative Directive of the CHU de Québec-Université Laval Research Centre: Closure of a Clinical Research Project Price List Forms and Resources

Administrative Directive of the CHU de Québec-Université Laval Research Centre: Closure of a Clinical Research Project

(Directive administrative du Centre de recherche du CHU de Québec-Université Laval : Fermeture d’un projet de recherche clinique)

Note: this document can be found in the “Study closure and archiving” (“Fermeture d’études et archivage”) section of the Toolbox (Boîte à outils).

In recent years, efforts have been made to identify and document the challenges involved in preserving and managing documents relating to a clinical research project when it closes.

A work team made up of members of the Clinical and Evaluative Research Platform (PRCE, Plateforme de recherche clinique et évaluative) and managers from the Financial Resources and Legal Services Departments and the Research Centre Management proposed a guideline to clarify and standardize the practices surrounding this neglected but important stage in the life of a project.

Particular attention to the financial aspect in your future research budgets is essential to plan for the costs inherent in taking care of the archiving of your research records.

For any clinical research project whose status has been authorized since 1 April 2018 and which has private or academic funding, the Directive applies when at least one of the following situations arises:

A retention period for study documents is specified in a contractual agreement ratified by the CHU de Québec-Université Laval, a research protocol, or any other official study document; or
A retention period is specified in the research protocol or in any other official study document required to obtain ethical approval; or
A retention period and retention conditions are required by applicable laws.

Although the Directive applies to non-funded projects and those conducted by residents, you should know that the archiving services offered by PRCE are free of charge for these specific cases.

Please do not hesitate to contact us if you have any questions about its application in your respective sectors.

Price List

The price list can be found in appendix 1 of the document Administrative Directive of the CHU de Québec-Université Laval Research Centre: Closure of a Clinical Research Project (updated version with indexed price list effective April 1 of each year). This document can be found in the “Study Closure and Archiving” (“Fermeture d’études et archivage”) section of the Toolbox (Boîte à outils).

Forms and Resources

Various documents are available in the “Study Closure and Archiving” (“Fermeture d’études et archivage”) section of the Toolbox (Boîte à outils), including a document called “FAQ: Frequently Asked Questions” (“FAQ : Foire aux questions”), the Electronic Archiving Preparation Kit (“Trousse de préparation à l’archivage électronique”) and the current version of the Administrative Directive of the Centre de recherche du CHU de Québec-Université Laval: Closing a clinical research project.