6 months after publication*
18 months after product abandonment OR 30 days after regulatory approval**
CLINICAL TRIAL MILESTONE
WHEN TO SHARE
WHAT TO SHARE
REGULATORY APPLICATION?
At trial registration
12 months after study completion
18 months after study completion
KEY:
Summary Data
Data commonly generated based on analysis of the individual participant data from a clinical trial (e.g., summary-level results posted on registries, lay summaries, publications, and clinical study reports (CSRs) used for regulatory application).
Individual Participant Data
Data that are collected from participants (e.g., the raw data) and then cleaned, abstracted, coded, and transcribed to become the analyzable data set.
Metadata
“Data about the data” (e.g., protocol, statistical analysis plan (SAP), and analytic code).
Registration Elements
Includes the 20 elements identified by the World Health Organization’s (WHO) International Clinical Trials Registry Platform along with narrative summaries of the trial protocol.
Data Sharing Plan
Describes what specific types of data will be shared at various time points and how to seek access to the data.
Summary-Level Results
A summary of clinical trial results (i.e., no individual participant data).
Lay Summaries
A brief, non-technical overview written for trial participants and the general public.
Post-Publication Data Package
A subset of the full data package supporting the findings, tables, and figures in the publication, including the full protocol, full SAP, and analytic code.
Full Data Package
The full analyzable data set, the full protocol, the full SAP, and the analytic code.
Post-Regulatory Data Package
The full data package plus the redacted CSR.
6 months after publication*
*No later than 6 months after publication applies to all studies, whether intended and or not intended to support regulatory applications and regardless of the timing of publication relative to study completion, although publication is most likely to occur after study completion.
18 months after product abandonment OR 30 days after regulatory approval**
**Sharing of the post-regulatory data package should occur: 30 days after approval or 18 months after study completion, whichever is later; 18 months after abandonment of the product or indication. This applies to all studies intended and to support regulatory applications, even if abandonment occurs prior to actual regulatory application.
Trial Design and Registration
Clinical trials are carefully designed. Before the first participant is enrolled, the protocol for conducting the trial and the statistical analysis plan (SAP) detailing the planned data analyses are developed. In 2006, the World Health Organization’s International Clinical Trials Registry Platform identified a set of 20 data elements for all trials to include in registration.
Participant Enrollment
Clinical trial data originate from patients and healthy volunteers who participate in studies. Raw data are collected between the time of first participant enrollment and study completion.
Study Completion or Termination
Study completion occurs when participants are no longer being examined or treated. In the case of termination, recruitment or participant enrollment halts prematurely and will not resume. Although study completion is often referred to as “last participant’s last visit” study completion may in fact include measurements that occur without face-to-face interaction between participants and investigators.
Publication
A subset of the data from the analyzable data set is used to generate the tables, figures, and results for published articles. Publication may occur at any time during the course of the clinical trial lifecycle, although it most often occurs after study completion. Several publications may result from one trial.
Regulatory Application-Yes
Around the world, clinical trials are required to be reviewed by regulatory authorities before a new medical product can be brought to market, or before a new indication, formulation, or target population can be approved for an intervention already on the market.
Regulatory Application-No
Clinical trials are also used to study interventions that do not involve regulated medical products, such as surgical techniques, behavioral interventions, means of improving disease management practice, or changes to a health care system.
