Ancillary Study Application

Ancillary studies may involve collection of additional data and/or samples from primary study participants, or use of existing data and/or samples for analyses or laboratory assessments that are not directly related to the specific objectives of the primary study as defined in the protocol document.

Ancillary Study Application Form

Please complete the ancillary study application form as it pertains to your proposed ancillary study and email to the respective study contact. The application must be reviewed by the primary study protocol team, including the Protocol Chair(s), Statistical and Data Management Center (SDMC), HPTN Laboratory Center (LC) and HPTN Leadership and Operations Center (LOC) representatives. The Investigator of Record for each study site to be involved in or affected by the ancillary study must also review the application as well.

After the primary study protocol team has reviewed the application, the HPTN LOC will request signature approvals from the Protocol Chair(s), SDMC, LC, and LOC representatives, as applicable. After these approvals are obtained, the HPTN LOC will send the application to the HPTN Executive Committee for final review and approval.