Office of Human Research
Page Title


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:  all Investigators involved in the conduct of FDA-regulated human subject research within Thomas Jefferson University.

Responsibility for executing this SOP:  Investigator and Designated Research Personnel

Approved By:


J. Bruce Smith, MD


Associate Vice President for Research


(signature on file at OHR)

Approved By:


Steven E. McKenzie, MD, Ph.D.


Vice President for Research


(signature on file at OHR)



This procedure describes the process for documenting all clinical study communications that are required during the conduct of FDA-regulated human subject research.


  1. The Investigator is responsible for ensuring that all participating Investigators and key study personnel understand required communications and the documentation of those communications.
  2. The Investigator is responsible for maintaining all original documentation or where appropriate, copies of documentation of communications among all affected parties. These communications are to be filed and maintained according to PM 503, Documentation and Records Retention.
  3. The Investigator is responsible for communicating to the IRB(s) of record, all appropriate and known information necessary to permit an informed decision-making process by the IRB during the initial and continuing review and approval(s) of applicable clinical studies.
  4. The Investigator is responsible for ensuring that all participating Investigators obtain written and dated approval from the IRB(s) of record for: the protocol, participant informed consent form, any materials used to recruit participants, and any changes to these documents prior to distributing the investigational product(s) and/or prior to implementing changes to an ongoing study.
  5. The Investigator is responsible for receiving and maintaining copies of IRB approvals from all participating Investigator(s).


3.1 General Communications

  1. All communications should be appropriately summarized and documented on the appropriate forms or other records, and distributed/filed as required by applicable standard operating procedures (SOP) and/or regulations.
  2. Participating Investigators and their key study staff will be trained on communication requirements during the initiation visit.
  3. The Investigator is expected to communicate regularly with the IRB, participating Investigators and appropriate government regulatory agencies about all study-related issues.
  4. The frequency of communications depends on the subject matter and context, but should be regular enough that parties are thoroughly apprised of current study status. OHR maybe consulted for guidance on determining the appropriate frequency.
  5. All pertinent written, verbal and electronic communications should be documented in sufficient detail, signed and dated by the person documenting the communication, and filed in the appropriate section of the Investigator's Regulatory Master File, and in the participating Investigator's correspondence file(s).

3.2 Investigator Communications with the IRB

  1. The Investigator and participating Investigators must communicate regularly and appropriately with their IRB(s) of record about all study-related issues, particularly those involving human participant safety and protocol adherence.
  2. With respect to federally funded research that requires an approved Federal Wide Assurance (FWA) from the Office for Human Research Protections, the Investigator will consult with the IRB to confirm the requirements for obtaining such an assurance.
  3. The Investigator will ensure that the study is properly submitted to Thomas Jefferson University’s IRB.
  4. Prior to study initiation the Investigator will assure that all participating Investigators will:
    • Complete the initial IRB submission packet
    • Include all attachments as directed, e.g., the protocol, protocol summary, Investigator Brochure, informed consent form and advertisements
    • Obtain documentation of full IRB approval for the protocol and informed consent form prior to study start
    • File all relevant IRB communications in the appropriate section of the Regulatory Master File and/or site study file
  5. During the time while the study is ongoing, the Investigator/designee and all participating Investigators/designees will:
    • Notify the IRB of any changes to the protocol and/or informed consent and of any new information on any investigational product, obtained directly or from another participating Investigator
    • Obtain IRB approval of amendments and revisions to study-related documents, such as advertisements, and document that approval prior to implementation except to eliminate apparent hazards to subject safety
    • Notify the IRB of any key study personnel changes affecting the oversight, management or conduct of the investigation
    • Provide the IRB with documentation of training and certification of key study personnel as required
    • Submit a periodic report for renewal of the study prior to the expiration of the current approval period, as required by the IRB
    • Promptly notify the IRB and applicable government agencies, if applicable, of all serious, unexpected or alarming events occurring during the approval period for the ongoing study either those observed by the Investigator or reported to him/her by other participating Investigators
    • Report all routine or expected adverse events to the IRB and any applicable government agencies (FDA, OBA) as part of the periodic or annual reporting requirements
    • Inform the IRB, OHR and Office of University Counsel (OUC) promptly when notified by FDA or another external authority of an impending inspection or audit
    • Provide final inspection or audit reports to OHR and upon request to IRB and OUC
  6. When the study is completed, the Investigator/designee will submit a final study report to the IRB and any applicable government agencies within the specified time following study completion

3.3 Investigator Communications with Participating Investigators

  1. Prior to distribution of the protocol, Investigator Brochure or other confidential documents, the Investigator will comply with the University's confidentiality requirements.
  2. Once the confidentiality requirements have been fulfilled, and the Investigator has reviewed the protocol and agreed to participate in the study, the Investigator or designee will provide a protocol signature page/Investigator Statement to the Investigator for signature.
  3. The Investigator or designee will request and review all pre-study regulatory documents, as well as all updated/revised documents when applicable.
  4. The Investigator will inform participating Investigators of all serious adverse events (SAE) through an IND Safety Report or other applicable required reporting mechanism.
  5. The Investigator will inform participating Investigators about the study's progress through written updates, teleconferences, or by other selected means (fax, e-mail).

3.4 Investigator Communication Records

  1. All pertinent verbal communications between the Investigator, his/her designees and other applicable parties will be documented (See SOP 201 Attachment A, Telephone Contact Log) or by other appropriate memorandum to the file. This record will be kept to follow and document the content and frequency of verbal communications, as well as assess the effectiveness of those communications. Each communication should be signed and dated by the party documenting the communication.
  2. The Investigator and all other parties will keep originals or photocopies of all relevant communications records, including facsimile confirmations and printed copies of e-mail, in the appropriate section of the Regulatory Master File or other appropriate study file.
  3. The Investigator will keep copies in the Regulatory Master File of all FDA documentation (Form FDA 483, Warning Letters) and resulting follow-up correspondence generated from the inspection of the Investigator, the IRB and other applicable Investigators.
  4. The Investigator will provide copies of relevant communications to OHR and other appropriate institutional officials.


21 CFR 312.32

IND safety reports

21 CFR 312.33

Annual reports

21 CFR 312.44


21 CFR 50

Protection of Human Subjects

21 CFR 56

Institutional Review Boards

FDA Information Sheets, October 1998

Investigator-IRB Interrelationship

May 1997

International Conference on Harmonisation; Good Clinical Practice:  Consolidated Guideline



Responsibilities of the Research Team


Assessing Protocol Feasibility


Prestudy Site Visit


Investigator and Site Initiation Meetings


Protocol Start-Up


Interactions with the Institutional Review Board


Regulatory Files and Subject Records


Adverse Event Reporting




The following definitions from the International Conference on Harmonisation, Good Clinical Practice: Consolidated Guideline apply to this SOP.

Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.

Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.


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