COMMUNICATION WITH SPONSOR OR CONTRACT RESEARCH ORGANIZATION (CRO)
Purpose
This standard operating procedure (SOP) describes the communication between key research personnel at the site and the sponsor/Contract Research Organization (CRO), including telephone and written interactions, during the entire course of a research study conducted at the Site and to ensure proper documentation of communications with the Sponsor/CRO concerning study activities.
Scope
This SOP applies in communications between the site and sponsors/C ROs involved in the conduct of the research study.
These communications serve to protect the safety and well-being of subjects by assuring that studies are conducted compliantly, sponsors/CROs are fully appraised of study site activities, and key research personnel is informed of new information about the study provided by the sponsor/CRO.
Any new study initiated during the active period of the SOP will be covered under the SOPs unless otherwise indicated. 1·1 necessary a study specific SOP may be prepared.
Procedure
General communications
Provide the sponsor/CRO a contact list of site personnel involved in the study start-up, along with each individual s role and responsibilities
• Communicate regularly, courteously, and in accordance with Site standards, with the sponsor /C RO about all study-related issues.
• Be familiar with the sponsor's SOPs pertaining to communications, in clouding reporting timelines and preferred communication mode.
• Keep originals or photocopies of all study-related communications, including taxes with corresponding confirmations, e-mails, and written summaries of phone conversations.
• File all communication documents in the appropriate section of the SIT E MASTER FIL E.
• Retain all sponsor-generated communications regarding the conduct of the study (e.g. teleconference announcement) in the correspondence section of the SITE MASTER FILE. Budget, payment, and, other contractual or financial communications should be filed separately from the regulatory binder. Insure information is communicated to the Principal Investigator (Pl) and other key research personnel as applicable.
Pre-Study communication
• The Clinical Trial Coordinator is responsible for sending the Confidentiality Agreement to the sponsor/CRO once reviewed and signed by Pl.
• Notify the sponsor/CRO of the Pl's decision to conduct the research study at the Site.
• Review the protocol and submit any questions concerning the interpretation of the protocol or conduct of the study to the sponsor/CRO in writing and file the copy in the Site Master File.
• Fill out the questionnaire provided by the sponsor/CRO regarding the study-related requirements.
• Prepare questions to clarify protocol procedures, subject eligibility criteria, and other study related issues in writing and file the reply in the Site Master file.
• The Pl/Co I will discuss how the site is equipped to perform the study. This discussion will include a description of the potential subjects available for the study and methods being considered for recruitment.
Communications while the study is ongoing
o Investigator/Clinical Trial Coordinator will submit the updated screening and/or enrollment logs to the sponsor /CRO by the preferred mode of communication.
• Notify the Sponsor /CRO about unanticipated issues, including adverse events (AEs) and Serious Adverse Events (SAEs), per the sponsor's definitions and timelines, as defined in the protocol or SOJ>.
• Communicate protocol deviations, as they occur. according to the sponsor's requirements.
• Submit completed CRFs (paper-based or e-CRF) to the sponsor/CRO in accordance with the Clinical Trial Agreement (CTA).
o Respond promptly to data queries as requested via fax, e-mail, and/or direct electronic data capture resolution. per the sponsor's requirements and document the same in the specified Site Master File.
o Communicate significant regulatory changes per the sponsor's requirements (e.g., IEC)
acknowledgment of an unanticipated issue or protocol deviation IEC approval of a revised consent document, etc.). Typically these documents are reviewed during interim monitoring visits; however specific sponsors/ CRO s may require prompt notification in specific circumstances.
Submit sponsor-generated protocol amendments to the IEC. Once approval is obtained, PI will
train the study team regarding the changes prior to implementation and the same will be documented and informed to the Sponsor/CRO.
Forward safety reports received from the sponsor (e.g., off-site SAE) to the Pl who will review the event and report to the IEC as per IEC SOP. Notification of other key research personnel and/or enrolled subjects may be necessary (e.g. new risk identified related to investigational treatment).
Communication alter study is completed
• Inform IEC regarding the scheduled site close-out visit.
• Communicate with the sponsor and confirm the close-out date.
• Provide the sponsor/CRO with any IEC-required correspondence (e.g. information requires in the IEC study closure letter) related to the study close-out.
• Ensure that all close-out activities are performed and all sponsor's requirements are met.
• After receiving the final close-out letter and study result from the sponsor, submit the same to the IEC in the required IEC format.
File all the communication in the appropriate section of the SITE MASTER FILE.
Sponsor Contact
I. Telephone Contacts - All study personnel will document critical conversations with the Sponsor/CRO in the source notes. especially those pertaining to eligibility criteria, protocol deviations, and serious adverse experiences. If requires the CLINICAL TRIAL COORDINATOR or delegate will fill in the Telephone Contact copy in the SITE MASTER FILE.
2. Letters and Faxes - All study personnel will make copies of all correspondence written to the Sponsor/CRO. The CLINICAL TRIAL COORDINATOR or delegate will file this correspondence in the SITE MASTER FILE.
3. e-mails - All study personnel will print out copies of critical e-mails with the Sponsor/CRO. The
The clinical Trial Coordinator or delegate will file this correspondence in the Site Master File and if required in the source notes.
At a minimum, the Sponsor/CRO should be notified:
o When the first subject is enrolled in the study.
o When there is a question concerning a potential subject's eligibility.
o When recruitment issues occur
o When a protocol violation occurs.
o When an SAE occurs.
Applicable Staff
This SOP applies to all the personnel of the clinical research team involved in communication with the Sponsor/CRO and responsible for the management of the data.
These include the following:
• Principal Investigator
• Sub Investigator
• Pharmacist
• Support Staff
• Clinical Trail Coordinator
END OF THE DOCUMENT
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3. STANDARD OPERATING PROCEDURE FOR COMMUNICATION WITH SPONSOR OR CONTRACT RESEARCH ORGANIZATION (CRO)
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