North Shore – LIJ Health System, Inc.

<Enter name of clinical trial site>

SOP TITLE: SPONSOR INTERACTIONS (INCLUDING PRE-STUDY AND CLOSE-OUT VISITS)
SOP #: <Enter SOP number>
Approval Date: <Enterdate the SOP is approved by local leadership.>
Site Implementation Date: <Enterdate the SOP is implemented at individual clinical trial site.>
Prepared by: <Enter name of author of the SOP.>
Last Revised: <Enterdate last version of the SOP was reviewed and approved.>
Effective Date: <Enterdate the SOP was first created and approved.>

OBJECTIVE:

  • The objective of this Standard Operating Procedure (SOP) is todescribe interactions with the Sponsor or CRO and the clinical trial site.

RESPONSIBILITIES:

  • The Investigator is responsible for complete and proper study communications with the Sponsor (or CRO).
  • The Clinical Research Coordinator is responsible for communicating with the Sponsor, as necessary, to ensure the proper conduct of the study and to inform the Sponsor of study activities.

PROCEDURES:

Preparation for Sponsor Visits

  • Pre-Study Inspection Visit:
  • Prior to meeting with the Sponsor, all staff involved with the clinical study are required to read the draft and/or final protocol under consideration, if available.
  • Each staff member prepares questions for the Sponsor in order to clarify protocol procedures, methodologies, subject entry criteria, required equipment, or any other study-related issues.
  • The Investigator or Clinical Research Coordinator should take the Sponsor on a tour of the facility, paying particular attention to equipment, exam rooms, test article storage room, and any other facilities. Discuss with the Sponsor why the site is equipped to perform the study properly.
  • The investigator introduces the Sponsor to site staff especially to the CRCs that will be directly responsible for the study. Discuss why the staff is qualified to perform the study.
  • The Investigator describes the subject population base and the methods that would be used to recruit subjects into the study. The team may enlist the input of the Clinical Research Service Recruitment Core to obtain health system information and/or develop a tentative recruitment plan.
  • To illustrate the quality of the documentation, the staff provides examples of source documentation from previous studies without breaching Sponsor or patient confidentiality.
  • The Clinical Research Coordinator provides study documentation as requested by the Sponsor, such as:

-Signed protocol

-Investigator and staff CV’s

-Copy of the Investigator’s medical license

-Signed FDA form 1572

-Financial disclosure document

-Budget

  • Initiation Visit:
  • All staff should review the protocol with the Sponsor to ensure correct understanding of protocol activities and methodologies.
  • The Investigator reviews any information in the Investigator's brochure that needs clarification.
  • All staff should prepare questions for the Sponsor in order to clarify protocol procedures, methodologies, subject entry criteria, required equipment, or any other study related issues.
  • The Clinical Research Coordinator will:
  • provide the Sponsor with an up-to-date regulatory file for review
  • ensure that clinical supplies have been inventoried (if they have arrived), or arrange for Sponsor to conduct inventory
  • review Case Report Forms (CRFs) (if they have arrived)with the Sponsor to ensure correct completion and interpretation
  • ensure all lab supplies have arrived and are complete
  • ensures that the Sponsor signs the visit log
  • The Investigator and Clinical Research Coordinator discuss test article storage requirements, dispensation, return, and dosing instructions with the Sponsor.
  • All staff should review the Sponsor's method for adverse event reporting.
  • Ongoing Study Visit:
  • The Clinical Research Coordinator and Investigator prepare questions for the Sponsor in order to clarify: protocol procedures, methodologies, subject entry criteria, required equipment, or any other study-related issues.
  • The Clinical Research Coordinator will:
  • ensure that all informed consent forms are signed and dated, and that a copy is in the subject’s file.
  • ensure that all CRFs and source documents are complete, and signed as required.
  • ensure that all IRB approvals are up-to-date and copies are in the study regulatory documentation file.
  • ensure the documentation in the regulatory file is up-to-date.
  • ensures that the Sponsor signs the visit log
  • The Clinical Research Coordinator and Investigator ensure that all adverse event data are complete on the CRFs and source documents.
  • The Coordinator or pharmacist ensures that the test article log is complete and up-to-date.
  • All staff plan for time with the Sponsor to review study progress and to discuss issues and corrections.
  • Close-out Visit:
  • The Clinical Research Coordinator ensures that all informed consent forms are signed and dated, and that a copy is in the subject’s file.
  • The Investigator and Clinical Research Coordinator ensure that all CRFs and source documents are complete, and signed as required.
  • The Investigator and Clinical Research Coordinator ensure that all corrections are made to the CRFs as requested.
  • The Clinical Research Coordinator or Pharmacist ensure that the test article log is complete and up-to-date, and that all test articles are returned from the subjects. Discusswith the Sponsor how many test articlesare to be returned to the Sponsor.
  • The Investigator ensures that all adverse event data is complete on the CRFs and in the source documents.
  • The Clinical Research Coordinator checks that all IRB approvals are up-to-date and that copies have been placed in the study regulatory documentation file.
  • The Clinical Research Coordinator ensures that the documentation in the regulatory file is up-to-date.
  • All staff plan for time with the Sponsor to review study progress and to discuss issues and corrections.
  • The Clinical Research Coordinator ensures the Sponsor signs the visit log.

Sponsor Communications

  • Appropriate staff communicates regularly with Sponsor by phone, fax, letter or e-mail. All critical conversations are documented.
  • The Clinical Research Coordinator notifies Sponsor when the first Subject is enrolled.
  • If requested, the Clinical Research Coordinator sends weekly subject enrollment information to Sponsor by fax or by e-mail.
  • The Clinical Research Coordinator notifies Sponsor when there is a question regarding a subject’s suitability for entry.
  • The Investigator or Clinical Research Coordinator notifies Sponsor immediately when a serious adverse event occurs.
  • The Clinical Research Coordinator keeps the Sponsor informed of subject recruitment progress.

Telephone Contacts with Sponsor

  • All staff should document all critical phone conversations, especially those pertaining to protocol deviations or subject issues.
  • If you need verification of the discussions, email the conversation summary to the Sponsor for acknowledgement, and request return of the document by fax or email.
  • All documents are placed in the studies regulatory documentation file.

Author: Date: ____/____/____

<Insert Name and Title>

Approved: Date: ____/____/____

<Insert Name and Title>

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