Office of Human Research
SOP No.: 401 INVESTIGATOR SELECTION
Author: Office of Human Research
Effective Date: October 1, 2007
Supercedes document dated: N/A
Last Reviewed on: N/A
Results of Review: N/A
This SOP pertains to: Any Thomas Jefferson University Investigator who is engaged in FDA-regulated human subject research that is to be conducted at sites other than, or in addition to, the Investigator’s own facility.
Responsibility for executing this SOP: Investigator and Designated Research Personnel
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR)
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR)
This procedure describes the process for identifying and qualifying potential candidates to serve as participating site Investigators for a Thomas Jefferson University Investigator.
2. GENERAL INSTRUCTIONS
- The Investigator will ensure that all study investigators will:
- Meet the experience and eligibility requirements to conduct the study
- Have sufficient time to complete the study
- Meet participant accrual and study population requirements
- Complete all participant information requirements for study documentation
- Have adequate support personnel with necessary training, experience and credentials
- Have facilities that are suitable to conduct the study
- The Investigator may confer with the OHR for advice in conducting assessments of a potential investigator's suitability. This may be particularly helpful in the setting of a multi-center trial.
- The Investigator is responsible for complying with all University policies on clinical study research agreement (contract) development
3. SPECIFIC PROCEDURES
3.1 Identifying Potential Investigators
The Investigator may use the following sources to identify potential investigators:
- Network of researchers known and recommended by colleagues or previous Investigators
- Medical consultants and physician referrals
- Professional contacts from previous research programs, medical conferences, scientific symposia, and professional meetings
- Literature review of the relevant medical specialty to identify opinion leaders and other published Investigators
- Professional and medical organization member lists and directories in the relevant scientific specialty
- To assess general interest and qualifications, the initial contact between a Investigator and a potential Investigator may be made by telephone.
- Before discussing the study details, the Investigator must comply with University policies regarding confidentiality.
- Once appropriate confidentiality is in place, the Investigator may send the clinical protocol to the potential Investigator.
- The Investigator or designee should conduct the telephone assessment and document the potential Investigator's responses (See SOP 401 Attachment A, the Potential Investigator Qualification Form).
- Based upon the data gathered during the telephone assessment, the Investigator will select the potential Investigators best suited to conduct the study, in terms of qualifications, facilities and potential for enrolling sufficient numbers of participants in a mutually agreeable period of time.
3.2 Investigator Agreements
- In consultation with appropriate institutional officials, the Investigator will ensure the preparation of a Clinical Trial Research Agreement that delineates the following requirements (See SOP 401 Attachment B):
- Proposed dates for conducting the study
- Study budget and reimbursement for direct and indirect costs
- Publication and presentation of the data from the study
- Summary of the Investigator's responsibilities (e.g., protocol compliance, IRB approval, informed consent from all participants, and compliance with applicable external and internal regulations, policies and procedures)
- A statement that the Investigator has read the contract and will comply with its requirements, and which must be signed by him/her
- Other Investigator interactions that OHR and other institutional officials believe should be specified in the contract
- Assignment of Inventions
- The Investigator will not proceed with any further aspects of the study until the potential Investigator has signed and returned the Clinical Trial Research Agreement.
- If applicable, the potential Investigator also should receive and return to the Investigator a Form FDA 1572 for completion and signature.
- Upon completion of these preliminary steps, the Investigator will provide the selected Investigator the final clinical protocol and proposed informed consent form for local IRB and other applicable internal regulatory action.
- The Investigator should obtain a signed Investigator Statement from each participating investigator.
- The Investigator will arrange for an initiation visit and site training to be conducted, at which time instructions about conducting the study, data handling and retention requirements, storage and dispensation of the investigational product, adverse event reporting and other study-related requirements will be provided.
3.3 Disqualified Investigators
- Prior to any initial contact with a potential Investigator, the Investigator or his designee should ascertain whether a potential Investigator has been debarred or otherwise disqualified from participating in FDA-regulated activities, and/or whether the potential Investigator has received any FDA Warning Letters in the recent past (See FDA website- http://www.fda.gov/foi/warning.htm).
- If an Investigator repeatedly fails to comply with the Investigator's requirements the investigator should be terminated from the study and be prohibited from participating in any future clinical studies (Reference SOP 505, Study Closeout Visit for termination procedure). Such investigators will be prohibited from participating in future clinical studies unless successful rehabilitation has been done by the OHR.