Item 29: Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators.
Example
“12.10.1 Intra-Study Data Sharing
The Data Management Coordinating Center will oversee the intra-study data sharing process, with input from the Data Management Subcommittee.
All Principal Investigators (both U.S. and host country) will be given access to the cleaned data sets. Project data sets will be housed on the Project Accept Web site and/or the file transfer protocol site created for the study, and all data sets will be password protected. Project Principal Investigators will have direct access to their own site’s data sets, and will have access to other sites data by request. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information.”113
Explanation
The validity of results from interventional trials can only be verified by individuals who have full access to the complete final dataset. For some multicentre trials, only the steering group has access to the full trial dataset in order to ensure that the overall results are not disclosed by an individual study site prior to the main publication. Many of these trials will allow site investigators to access the full dataset if a formal request describing their plans is approved by the steering group. The World Medical Association supports the principle that trial investigators retain the right to access data.363 However, among protocols of industry-initiated randomised trials published in 2008-9 in the Lancet or approved in 2004 by a Danish ethics committee, 30-39% stated that the sponsor owned the data while 0-3% stated that principal investigators had access to all trial data.10;364 Similar constraints were found in Danish trial protocols from 1994-5.10
The protocol should identify the individuals involved in the trial who will have access to the full dataset. Any restrictions in access for trial investigators should also be explicitly described.
| 28: Declaration of interests | 30: Ancillary and post-trial care |
