About

653 Members

326 Institutions

The Clinical Trials Registration and Results Reporting Taskforce is a national consortium of members of academic medical centers, universities, hospitals, and non-profit organizations focused on the implementation of domestic clinical trials registration and results reporting requirements in the ClinicalTrials.gov public repository.

The Taskforce membership is comprised of volunteers; there is no funding or formal support structure behind the group’s efforts. There is no regulatory mandate to join the Taskforce; however, only members are able to access all of the resources developed by the group. Some resources, at the discretion of the group, are made publicly available through this website.

Mission:

This group will focus on the requirements for clinical trials registration and results reporting that affect US academic health centers. The group’s objectives will include:

Understanding and applying the requirements;
Identifying best practices in managing the requirements;
Developing tools to assist both regulatory support and investigators in meeting the requirements;
Serving as a communication forum to support academia in meeting clinical trials registration/reporting requirements

The Data Transparency Subcommittee develops guidance documents to help member institutions, and is currently reviewing requirements to suggest standards for NIH Dissemination Plans (as required in NIH Policy on the Dissemination of Clinical Trial Information) and International Committee of Medical Journal Editors (ICMJE) Data Sharing Statements. Other requirements will be reviewed on an as-needed basis.

Building on a survey conducted in 2016-2017, we are conducting a qualitative study to learn how academic organization can meet trial registration and results reporting requirements. We are interviewing PRS administrators and others about organization policies and procedures. We hope to learn about facilitators and obstacles to compliance of all kinds, and we want to identify “best practices” to share with the community.

The Survey Subgroup conducted an online survey of PRS administrators to identify policies, procedures, and resources to support clinical trial registration and results reporting at academic organizations in the US. The group met beginning in 2016 to design survey questions, develop a study protocol, lunch the survey, and write a manuscript describing the results. The 2017 survey provides a baseline for follow-up surveys and analyses of trends, and the Survey Subgroup is currently developing a second survey to be conducted in 2018. If you have questions, or to learn more, please contact Tony ([email protected]).

The Subgroup would like to thank personnel at NIH for their assistance in developing and conducting the survey. We would also like to thank the Taskforce members for the robust response rate and specifically the 13 members of the Taskforce who volunteered to pilot the survey.

The Training Subcommittee works to develop and periodically update training materials for institutions to use with ClinicalTrials.gov users, whether faculty, administrators, or study staff. These include slide set templates that can be customized for institutional use.

About

Data Transparency Subcommittee

Qualitative Subcommittee

Survey Subcommittee

Training Subcommittee