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Policies and Procedures: Ancillary studies of NINDS-supported Clinical Trials and Epidemiological studies

It is generally recognized that large clinical trials and epidemiological studies offer opportunities to investigate many questions and hypotheses that are related to the scope and intent of the study but are not part of the study objectives. These "ancillary studies" or substudies may include studies that simply require new analyses of existing data; studies requiring new analyses of existing specimens; or studies requiring collection and analysis of new data or new specimens. Because ancillary studies may have an impact on the progress and scientific integrity of the parent study, it is essential that no such ancillary study is initiated without appropriate evaluation of its merit, relevance to the goals of the parent study, and impact on the parent study protocol and progress. Ancillary study proposals should be formally reviewed and approved by the leadership of the parent study and the NINDS. The review and approval of the Data and Safety Monitoring Board (DSMB) or Observational Study Monitoring Board (OSMB) is also required.

The following are suggested guidelines for establishing ancillary study policy and obtaining appropriate review and approvals.

  1. General policy/procedures for ancillary studies in NINDS-supported clinical trials and epidemiologic studies
    1. Definition: a research activity undertaken to address a scientific question relevant to the parent study that requires access to data or records from the parent study and/or involves collection of additional data, specimens, or records from patients enrolled in the parent study.
    2. A policy for proposing, reviewing, and approving ancillary studies is an essential part of the manual of operations of the parent study.
    3. A list of all proposed and approved ancillary studies will be maintained by the coordinating center.

  2. All ancillary/substudy concepts must be reviewed and approved by the Steering Committee and by the Data and Safety Monitoring Board/Observational Study Monitoring Board before initiation.
    1. Review and voting by the SC will take place at a face-to-face meeting or conference call with all members present; if this is not feasible, mail review and voting may be substituted.
    2. A written ancillary study proposal (see item 3 below) and study protocol must be provided before the SC votes.
    3. SC members must have time to review and digest the proposal before a vote is taken. Review is based on the criteria specified in item 4 below.
    4. The data center must have an opportunity to assess the impact on data management and study administration before the vote is taken.
    5. Once approved by the SC, protocols will be forwarded to the DSMB/OSMB by the NINDS representative; results of DSMB/OSMB vote will be communicated to the SC by the NINDS representative.

  3. Procedure for proposing ancillary studies:
    1. A form for submitting ancillary study proposals should be developed; it should include the following information:
      • title, purpose, abstract
      • PI, other investigators
      • performance sites
      • nature and extent to which the proposed study is likely to affect the parent study
      • type and amount of specimens or records required from the parent study
      • type and amount of data/specimens to be generated by the proposed study
      • timing of any additional data/specimen collection from patients in the parent study
      • amount of effort required from the data center to support the proposed study
      • amount of effort required from site investigators to support the proposed study
      • added patient burden (i.e., additional consent, additional data collection, additional visits/contacts)
      • IRB reviews and approvals
      • funding source
    2. The proposal and protocol will be forwarded to the SC chairman for distribution to the SC members at least one week before the meeting.

  4. Criteria for Steering Committee approval of ancillary study
    1. The proposed study addresses a question of importance to the parent study.
    2. The proposed study should not compete with any previously approved ancillary study.
    3. Conduct of the study must not adversely affect the parent study.
    4. Funding for the study will be obtained by the PI and will be independent of the parent study funding.
    5. Procedures for accessing necessary data and records from the parent study are explicit and acceptable.
    6. The proposing PI has the appropriate expertise and facilities to conduct the study.
    7. Plans for publication and authorship of study results are appropriate, including SC review and approval of manuscripts.

Last updated November 24, 2008