Supplemental Evidence and Data for Systematic Reviews (SEADS) Guidelines

For those submitting SEADS, it is most helpful to the AHRQ TA Program to provide—

• A list of all completed studies your company or organization has sponsored for this indication. In the list, indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
• For completed studies that do not have results on ClinicalTrials.gov, a summary that includes the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, and effectiveness/efficacy and safety results.
• A list of ongoing studies your company or organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.
• A cover letter that includes a notation of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your company for this indication and an index outlining the relevant information in each submitted file.

These materials can be submitted to epc@ahrq.hhs.gov until the deadline posted on the AHRQ TA Program Web page which is usually 4 weeks after the posting date of the protocol in order to allow adequate time for preparation. Notification of the opportunity to submit SEADS will also be sent to relevant organizations when the protocol has been posted. Organizations that wish to identify an individual or individual(s) to receive these notifications may send an email with contact information to epc@ahrq.hhs.gov.

Your contribution is very beneficial to the AHRQ TA Program. Materials submitted must be publicly available or can be made public. The AHRQ TA Program cannot use the following: materials that are considered confidential; marketing materials; pharmacoeconomic, pharmacokinetic or pharmacodynamic studies; study types not included in the review; or information on indications not included in the review.

This is a voluntary request for information, and the submitter must bear all costs for complying with this request.