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Changes to Investigator or Site Information

Sponsors

All submissions for review and approval of research must identify the principal/qualified investigator (PI/QI) as the person responsible for the leadership and conduct of the research at the given study site(s).

To ensure successful research, PIs/QIs often employ a team approach where significant research-related duties are delegated to other appropriately qualified individuals.

Individual members of the research team designated and supervised by the PI/QI to perform critical research-related procedures and/or to make important research-related decisions are considered sub-investigators (Sub-Is). While research-related duties can be delegated by the PI/QI to other qualified staff, overall responsibility for the research cannot be delegated and always rests with the PI/QI. Questions about who should be considered the PI/QI and/or Sub-I at a study site for a given protocol should be directed to the study’s sponsor/CRO contact.

Principal/Qualified Investigator (PI/QI) Changes

If there will be a change of PI/QI, submit a Change of Investigator Form and await approval prior to the new PI/QI taking over the study. Failure to do so is generally considered reportable noncompliance with Board requirements. Occasionally, safety concerns or unforeseen circumstances may require implementation of a PI/QI change prior to approval. When PI/QI changes are implemented in order to eliminate an apparent immediate hazard to a research subject without prior approval, it must be reported to Schulman within 10 business days.

For PI/QI changes, the submission should also include:

  • New PI’s/QI’s Curriculum Vitae (CV), reflecting current experience and signed and dated within the past 2 years
  • Documentation from the sponsor/CRO approving the change of PI/QI (if applicable)
  • New PI’s/QI’s current medical license (Canada, Mississippi and Puerto Rico only)

Sub-Investigator (Sub-I) Changes

If there will be a change of Sub-I (removal and/or addition), submit a Change of Investigator Form and await approval prior to implementing the change. Failure to do so is generally considered reportable noncompliance with Board requirements. Occasionally, unforeseen circumstances may require implementation of a Sub-I change prior to approval. When Sub-I changes are implemented due to unforeseen circumstances prior to approval, it must be reported to Schulman within 10 business days.

For Sub-I additions, the submission should also include CVs for *each new Sub-I, reflecting current experience and signed and dated within the past 2 years.

* CVs are not generally required for new Sub-Is on studies that have been qualified by the Board as minimal risk and/or non-interventional.

Site Location Changes

If there will be a change of primary or additional site location, submit a Change of Site Information Form and await approval prior to implementing the change. Failure to do so is generally considered reportable noncompliance with Board requirements. Occasionally, unforeseen circumstances may require implementation of a site location change prior to approval. When site location changes are implemented due to unforeseen circumstances prior to approval, it must be reported to Schulman within 10 business days.

Forms and corresponding documentation can be submitted to Schulman via:

If the change submission results in the need to revise the most recent Schulman-approved informed consent(s) (ICs), the site and designated contact person from the sponsor or CRO will receive the corresponding revised ICs with the change approval document. For more information on revised ICs, please see Revised Informed Consent.