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Evidence Reports All of EHC



Supplemental Evidence and Data Guidelines

Your contribution of supplemental evidence and data (SEADs) is most helpful to the Effective Health Care (EHC) Program when it includes the following:

  • A list of all completed studies your company has sponsored for this indication. Please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
  • A summary of completed studies that do not have results on ClinicalTrials.gov 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    • number of patients screened/eligible/enrolled/lost to followup/withdrawn/analyzed
    • effectiveness/efficacy and safety results
  • A list of ongoing studies your company 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 indicates whether you have submitted information on 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.

The contents of all submissions will be made available to the public upon request. Please do not submit 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. Such materials cannot be used by the EHC Program.

Material submission is voluntary, and the submitter must bear all costs for complying with this request.

For further information or assistance, please contact epc@ahrq.hhs.gov.

Public reporting burden for this collection of information is estimated to average 15 minutes per response, the estimated time required to complete the survey. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer Attention: PRA, Paperwork Reduction Project (0935-0231) AHRQ, 5600 Fishers Lane, #07W41A, Rockville, MD 20857.

Section 944 (c) of the Public Health Service Act [42 U.S.C. 299c 3(c)] requires that information collected for research conducted or supported by AHRQ that identifies individuals or establishments be used only for the purpose for which it was supplied unless they consent to the use of the information for another purpose.

OMB Control Number 0935-0231

Expiration Date 11/30/2025

Page last reviewed November 2022
Page originally created September 2017

Internet Citation: Supplemental Evidence and Data Guidelines. Content last reviewed November 2022. Effective Health Care Program, Agency for Healthcare Research and Quality, Rockville, MD.

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