The master SOP shall be securely filed and used only for making further controlled copies if required Copies of the approved SOP will be placed in an accessible location for relevant staff to access; electronic copies should be provided as locked PDFs. All trial relevant researchers and research staff will be notified of this new SOP Recall of superseded SOPs The superseded master SOP be filed securely as a record of previously used SOPs Other copies of a superseded SOP (electronic or hard copies) shall be deleted or destroyed GLOSSARY Clinical Research Coordinators A research worker works at a clinical research site under the immediate direction of a Principal Investigator, whose research activities are conducted under Good Clinical Practice guidelines. May also be called Coordinator” or Coordinator” or coordinator”. (ARCP “Clinical “Research “study Definition.) Controlled Document A document that has been created or modified through a controlled documentation process. Such a document cannot be modified without going through a documented process of change control. A controlled document will have a version number, an approval signature and be dated. In most cases there is a review and authorisation step in addition. Delegate A person delegated specific but appropriate QA tasks in relation to SOP generation Document controller A person responsible for the distribution and maintenance of SOPs. Document reviewer A person delegated the task of reviewing SOPs by QA or the Institution or Investigator. Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of subjects are protected. The organisation conducting the research, following a human research ethics committee (HREC) approval, must authorise research governance/SSA before a research project can commence at that site. International Conference on Harmonisation (ICH) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs. Investigator
The master SOP shall be securely filed and used only for making further controlled copies if required Copies of the approved SOP will be placed in an accessible location for relevant staff to access; electronic copies should be provided as locked PDFs. All relevant researchers and research staff will be notified of this new SOP Recall of superseded SOPs The superseded master SOP be filed securely as a record of previously used SOPs Other copies of a superseded SOP (electronic or hard copies) shall be deleted or destroyed GLOSSARY Clinical Research Coordinators A research worker works at a clinical research site under the immediate direction of a Principal Investigator, whose research activities are conducted under Good Clinical Practice guidelines. May also be called “Clinical Coordinator” or “Research Coordinator” or “study coordinator”. (ARCP Definition.) Controlled Document A document that has been created or modified through a controlled documentation process. Such a document cannot be modified without going through a documented process of change control. A controlled document will have a version number, an approval signature and be dated. In most cases there is a review and authorisation step in addition. Delegate A person delegated specific but appropriate QA tasks in relation to SOP generation Document controller A person responsible for the distribution and maintenance of SOPs. Document reviewer A person delegated the task of reviewing SOPs by QA or the Institution or Investigator. Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. The organisation conducting the research, following a human research ethics committee (HREC) approval, must authorise research governance/SSA before a research project can commence at that site. International Conference on Harmonisation (ICH) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs. Investigator
sop_-_creation_implementation_and_revision_2017_07_13_0.docx