16.1 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 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). 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 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. 16.2 Scope This SOP will apply to all study team members conducting studies in [Institution]. 16.3 Procedure 16.3.1 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 Trial Coordinator (CTC)/ team member. The Medical Director and department of clinical research recommend that all 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. 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 CTC. 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.
16.1 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 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). 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 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. 16.2 Scope This SOP will apply to all study team members conducting studies in [Institution]. 16.3 Procedure 16.3.1 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 Trial Coordinator (CTC)/ team member. The Medical Director and department of clinical research recommend that all 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. 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 CTC. 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.