Table 2.

Summary recommendations for obtaining individual participant data

Requesting data through personal contact or data sharing repository

Review the data sharing policy of the study’s sponsor organization.

Data sharing requests can be submitted using a professional email account or through a data sharing repository.

Contact data repositories to inquire about datasets not listed for request.

In addition to the IPD, consider requesting access for the study protocol, analysis plans, analysis-ready dataset, meta-data, annotated case report forms, and clinical study report.

Multiple contact attempts occurring over months or years may be required. Send emails on behalf of well-known researchers, those with personal connections to study authors, or from well-known research organizations to assist in garnering a response.

Discuss data sharing through teleconferences or in-person meetings rather than fragmented email correspondence whenever possible.

Offer to complete the essential data sharing tasks and provide necessary funding for researchers who may lack the time or organizational resources to share data.

Record the names, affiliations, contact information and roles of internal and external data sharing stakeholders throughout the data sharing process.

Incentives for data contributors

Offer authorship or other incentives (eg. financial, acknowledgement) to those deserving credit for generating primary data.

Setting up a data sharing agreement

Adapt previous data sharing agreements or existing templates to suit specific studies and institutional policies of study sponsors. Seek assistance form your institution’s industry liaison office.

Time to data retrieval and refused requests

Continue to contact study stakeholders until a refusal to share data has been confirmed.

Seek reasoning for denied data sharing requests and attempt to develop solutions to data sharing barriers.

Effective communication and negotiation with primary study stakeholders may allow sharing of IPD before or immediately after publication of primary study results.

Document non-responses and refused data sharing requests for report in results publications.

Managing retrieved IPD

Review the primary study protocol, results publications, clinical study reports, annotated case report forms and other shared files before and alongside data processing.

Datasets which could not be shared may be incorporated into analysis using methods which combine study level and IPD.

Allow data sharing organizations to review and comment on analysis prior to publication, ensuring accurate interpretation of shared data.

Identify projects emerging from IPDMA before results publication or prior to deletion of shared study data.

Confidentiality and data storage

Research local laws and sponsor policies pertaining to the storage and sharing of personally identifying information.