STUDY TEAM TRAINING AND STUDY HANDOVER
Purpose
This SOP defines the procedure and recommendation of training of study team members and adequate handover to CTC/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 member 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 ). Some training may be obtained through internal hospital accepted training and certification program(s) or through external hospital accepted training and certification program(s).
The purpose of a handover is to ensure continuity of operations, when the study team member, usually responsible, is not available clue 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 team members conducting studies in SITE
Procedure
Study Team Training
o 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 Trial Coordinator (CTC)/ team member.
o The Investigators, CTC 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.
o Each Investigator. CTC 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 ere. 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, Pl and ere will attend the Investigator Meeting (organized by Sponsor) and complete all required training for a study. If Pl is unable to attend the meeting, Pl can recommend other study team member(s) to attend the IM. Pl should be informed regarding the study contents discussed in IM.
• Before study initiation Sponsor/CRO will organize SIY meeting at sit e to train all study team members and all study team members should attend the meeting for thorough understanding of the study.
• Pl and study team member(s) should be prepared to demonstrate all training received.
• SIYs. 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 Handover
If any stud y 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 Pl, the identified person should be brie fed in time before the person goes on leave to all ow for any follow up questions.
Prior to leaving the study. the existing study team m ember should complete the following:
o Training on protocol and procedures e.g. SOPs and explanation of relevant documents
o Information regarding study subjects. study documents and al l study related activities
o Outstanding data entry and/or data queries
o Training to complete source documents
o Explanation on the objectives & priori ties
o Notification to the sponsor or the study team changes
o Notification to the active subjects of the study team changes if the research team contact in formation will change for the subjects.
o Provide a list of study-specific contacts (e.g., sponsor, monitor, vendors involved etc.)
o Provide a list of outstanding issues
o 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 handover. If there is a change in Pl, the following documents need to be revised and completed;
o In form Sponsor and IEC regarding the change in Pl in the Study team.
o 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.
o Update the Form FDA 1572 or the Investigator Agreements, Investigator Undertaking and other required forms
o Update the Duty Delegation log
o Ensure that the new Pl has completed the SOP required training and study-specific training. Written hand over should be given in order to cnst1re the continuity of work. The format can be a briefing note. a check list. or a schedule prepared to give all information.
When the study member returns from leave a hand over should be prepared to give updates on the status of the tasks.
The casting and new study team member should document the study handover in a note to fi le or other documentation in the TMF. The note should contain some of the inters above and the date of the handover. The new stud y team member should obtain documented study -specific training and any required approvals prior to being added to the duty delegation lo
Applicable Staff
This SOP applies to all the existing personals of the clinic al 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)
• CTC
END OF THE DOCUMENT
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