SOP for Roles and Responsibilities of Clinical Research Coordinators

Purpose

This SOP defines the procedure and recommendation of training of study team members and adequate handover to CRC/study team member, to ensure that the patient safety, protocol compliance, data integrity and overall quality assurance at the investigational site is protected and integrated as per the applicable regulations and guidelines.

Study team members must understand the responsibilities of the trials conducted at site and be appropriately qualified by education, training and/or experience to perform his or her research related task(s).

The purpose of a handover is to ensure continuity of operations when the study team member, usually responsible, is not available due to temporary or permanent absence. A handover can be supported by a discussion to explain the status of the tasks, a summary of the work status in an email/ memorandum or, a more detailed file.

Scope

This SOP will apply to all study research coordinator at site management office in XXX and MRC.

Responsibilities

• Study start up activities like Feasibility/Synopsis and Clinical disclosure agreements.
• Reviews and develops a familiarity with the study protocol (e.g. study procedures and timelines, inclusion/exclusion criteria, confidentiality).
• Document date of training and signatures of study personnel trained on study specific training log.
• Collect documents needed to initiate the study and submit to the sponsor (e.g. forms 1572, CVs, etc.)
• Conduct or participates in the informed consent process, including interactions with the IEC and discussions with research participates, including answering any questions related to the study.
• Obtain appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed/Dated.

• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential subject eligibility or exclusion. Creates and utilizes Eligibility Checklist to inclusion/exclusion criteria.
• Coordinate participant tests and procedures, including scheduling and registration of subjects with hospital Outpatient/ in patient departments at site (e.g. radiology for CT scan).
• Collect data as required by the protocol. Assure timely completion of Case Report Forms
• Maintain study timelines per the event schedule (e.g. subject visits, procedures and data entry are completed within the allotted time window per study protocol).
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or UCSF Policy on Investigational Drug/Device Accountability.
• Complete study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Maintain effective communication with sponsor, research participants, IEC of XXX and PI during the course of the study.
• Work with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management.
• Report all findings and correspondence from external or internal study monitoring and audits to the research manager and department Chair in a timely manner.
• Assist the PI in reporting of research-related incidents, including protocol deviations or potential violations, as well as findings and correspondence from external or internal study monitoring and audits to the IEC of XXX, in a timely manner.
• Assist the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with Federal regulations and Hospital/University policies and procedures.
• Study Handover: If any study team member is planning for leave or to resign, he/she must ensure that the proper handover is given to concern person identified by the PI, the identified person should be briefed in time before the person goes on leave to allow for any follow up questions.

• Prior to leaving the study, the existing study team member should complete the following:

1. Training on protocol and procedures
2. Information regarding study subjects, study documents and all study related activities
3. Outstanding data entry and/or data queries
4. Training to complete source documents
5. Explanation on the objectives & priorities
6. Notification to the sponsor of the study team changes
7. Notification to the active subjects of the study team changes if the research team contact information will change for the subjects.
8. Provide a list of study-specific contacts (e.g., sponsor, monitor, vendors involved etc)
9. Provide a list of outstanding issues
10. The leaving person has to make sure that the documentations concerned for the tasks is up to date and easily available, and if needed, revise it when preparing the hand over.

If there is a change in PI, the following documents need to be revised and completed;

1. Inform Sponsor and IEC of XXX regarding the change in PI in the Study team.
2. Consider revising the protocol and informed consent form, as appropriate. Also consider notifying current subjects; correspondence sent to all subjects must be approved by the IEC, if applicable.
3. Update the Form FDA 1572 or the Investigator Agreements, Investigator Undertaking and other required forms
4. Update the Duty Delegation log
5. Ensure that the new PI has completed the SOP required training and study-specific training
6. Written hand over should be given in order to ensure the continuity of work. The format can be a briefing note, a check list, or a schedule prepared to give all information.

ALSO READ: SOP for Case Report Forms and Source Documents

• When the study member returns from leave a hand over should be prepared to give updates on the status of the tasks.
• The existing and new study team member should document the study handover in a note to file or other documentation in the TMF. The note should contain some of the items above and the date of the handover. The new study team member should obtain documented study-specific training and any required approvals prior to being added to the duty delegation log.

Procedure

Appointment Procedure:

• The site clinical research coordinators have been appointed through respective site management organisations. Before assigning the CRC to XXX, the Organisation has to intimate the site personnel via mail or letter for communication with proper appointment letter and period of agreement (If applicable).

Study Team Training:

• On appointment, all study team members will be given an appropriate study depending on the job specification to possess the right experience and qualifications and further training may be provided to bring them up to the required level for specific tasks. Duty delegation / job responsibility document will be given to every Clinical research Coordinator/team member.
• The Medical Director and department of clinical research recommend that all Investigators, CRC and other study team members must undergo training which will enable them to understand their responsibilities, applicable regulations, guidelines and research studies and training should be documented in the training log.
• Each Investigator, CRC and study team members will review and learn the site's SOPs. It is recommended that SOP training must be included in the orientation of new clinical research personnel. All applicable clinical research personnel should be knowledgeable of new or revised SOPs.
• Good Clinical Practice (GCP) is a universal standard in clinical research that must be followed in every research protocol. GCP training and education are recommended for research team members, especially the Investigator and CRC. However, any member of the research team with a significant role in the conduct of a research study must be knowledgeable in GCP. All members of the clinical research team should GCP trained and certified.
• If scheduled, the PI and CRC will attend the Investigator Meeting (organized by Sponsor) and complete all required training for a study. If PI is unable to attend the meeting, PI can recommend other study team member(s) to attend the IM. PI should be informed regarding the study contents discussed in IM.
• Before study initiation the Sponsor/CRO will organize SIV meeting at site to train all study team members and all study team members should attend the meeting for thorough understanding of the study.
• In the study start up activities like feasibility/study synopsis CRC should intimate to the site personnel.

• The PI and study team member(s) should be prepared to demonstrate all training received. CVs, GCP and other training certificates should be updated as required. It is recommended that an assessment of the employee’s knowledge of the regulations and guidelines can be conducted upon recruiting and on a regular basis. It is recommended that an assessment of any additional protocol-specific skill requirements be conducted prior to activation of each new study
• Study team members should attend the course to acquire training or to update themselves.
• PI can also train the study team and should maintain the training record.
• It is recommended that the PI and study team must maintain the Site SOP training Record.
• Entry in to Study drug store at site: The access will be given only blinded/unblinded pharmacist and who are delegated (Delegation log) in clinical study for the IP management. The entry access will be restricted.

Applicable Staff

This SOP applies to all the existing personals of the clinical research team and any new member appointed who may be responsible for training and study handover as mentioned in this SOP (as per the delegation log).

These include the following:

• Investigator
• Research Team (listed in the delegation log)
• Clinical Research Coordinator

Staff responsible for Implementation:

• The department and Investigator will ensure that the research team involved in the conduct of the study will comply with this site SOP.
• The department and PI will ensure that at the time of implementation of the SOP, which the research team at the site management office (clinical research unit) in XXX Hospital and MRC, Belagavi are trained and in the event that an SOP is modified, provide training regarding the change(s) and ensure their compliance with the changes.
• It is the responsibility of each individual who are about to go on short / long term absences or leave their current position / the Agency/third party employees to prepare a hand over file.

Revision History

Nil

ALSO READ: SOP for Case Report Forms and Source Documents