C1.7 Research in the Is unaware of the HR Is aware of the HR Is able to operate the HR Is able to advise and Deals with escalated NHS HR Good Good Practice Good Practice but is Good Practice Resource guide others on all problems associated with – Practice Resource Pack Resource Pack. not part of their role. Pack system effectively aspects of the HR Good wider HR contractual (Research Passport and is able to escalate Practice Resource Pack. processes. System). issues where necessary. C2. Understanding the principles of Good Clinical Practice and Good Research Practice within R&D C2.1 Good Clinical Is unaware of the Is of the Understands the principles Understands all the Challenges poor practice Practice (GCP) and principles and principles and and requirements of GCP principles and according to GCP and good research requirements of GCP requirements of GCP and good research requirements of GCP good research practice practice. and good research and good research practice and how they and good research principles and practice.. practice but does not apply to different studies practice and promotes requirements and understand their i.e. GCP is a legal training and adherence recommends and secures application. requirement for regulated as applicable. the necessary improvement. clinical trials. C2.2 Adverse Event Is unaware of Is aware of adverse Is aware of adverse event Is able to handle queries Acts and advises on the Reporting. adverse event event reporting but reporting and able to about the reporting of process and reporting. unsure of the handle basic queries about adverse events and can requirements for adverse process. the reporting of adverse administer the process event reporting. events. for reporting adverse events. C2.3 Breaches of Good Is unaware of GCP. Is aware of GCP but Is of GCP and able to Is able to handle queries Is able to act and advise Clinical Practice (GCP). unsure of the process handle queries about the about the reporting of on the requirements of relating to breaches. reporting of GCP breaches. GCP breaches and can reporting GCP breaches administer the process and can secure the necessary improvement.
C1.7 Research in the NHS – HR Good Practice Resource Pack (Research Passport System). Is unaware of the HR Good Practice Resource Pack. Is aware of the HR Good Practice but is not part of their role. Is able to operate the HR Good Practice Resource Pack system effectively and is able to escalate issues where necessary. Is able to advise and guide others on all aspects of the HR Good Practice Resource Pack. Deals with escalated problems associated with wider HR contractual processes. C2. Understanding the principles of Good Clinical Practice and Good Research Practice within R&D C2.1 Good Clinical Practice (GCP) and good research practice. Is unaware of the principles and requirements of GCP and good research practice.. Is of the principles and requirements of GCP and good research practice but does not understand their application. Understands the principles and requirements of GCP and good research practice and how they apply to different studies i.e. GCP is a legal requirement for regulated clinical trials. Understands all the principles and requirements of GCP and good research practice and promotes training and adherence as applicable. Challenges poor practice according to GCP and good research practice principles and requirements and recommends and secures the necessary improvement. C2.2 Adverse Event Reporting. Is unaware of adverse event reporting. Is aware of adverse event reporting but unsure of the process. Is aware of adverse event reporting and able to handle basic queries about the reporting of adverse events. Is able to handle queries about the reporting of adverse events and can administer the process for reporting adverse events. Acts and advises on the process and requirements for adverse event reporting. C2.3 Breaches of Good Clinical Practice (GCP). Is unaware of GCP. Is aware of GCP but unsure of the process relating to breaches. Is of GCP and able to handle queries about the reporting of GCP breaches. Is able to handle queries about the reporting of GCP breaches and can administer the process Is able to act and advise on the requirements of reporting GCP breaches and can secure the necessary improvement.
Competencies%20-%20Nov%202013.docx