Clinical Research Sop Template Free

Sop 404 protecting confidentiality of study subjects.
Clinical research sop template free. In clinical research sops help define the group s e g unit division department institution etc standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional state and federal guidances. Sop 503 electronic records. And the hiring training and retention of coordinators and other site personnel. Sop 502 source documentation.
Sop 405 study visits. Nci ccr standard operating procedures sops related forms policies and guidelines. The templates below have been shared by other groups and are free to use and adapt for your researchstudies. Focus on improved data quality.
Sop 406 payments to subjects. Conducting the study in accordance with the irb approved protocol as it is written. Sop 501 case report forms. Sample user standard operating procedure version.
To share your own templates and sops or comment on these please. Sop 505 printing and certifying medical records. Standard operating procedures sops are uniformly written procedures with detailed instructions to record routine operations processes and practices followed within a business organization. Mop founded in federal regulations and guidance good clinical practice guidelines and institutional policies and guidance general processes common to running all studies infrequent changes established in a grant protocol and or irb application study specific processes to gather data for one study s research aims.
Use a training log to record all training that the site study staff completes signing the log entry for. Dghi is pleased to share these documents with others who are working in resource limited locations. Clinical trial site operations templates and sops conducting clinical trials and building a high capability coordinator team. Download phase 1 clinical trial protocol template word.
The principal investigator is responsible for. Sop 504 archiving study records. Protocol and gcp compliance. Please ensure that you read and adapt them carefully for your own setting and that you reference global health trials and the global health network when you use them.
Download these 37 best free standard operating procedure sop templates to study and review in order to prepare your own sop for any kind of situation easily. Protocol deviation reporting and documentation. By training staff members on the research protocol you ll help them meet compliance standards and understand the purpose and details of the study. Sop 602 fda audits.
Standard operating procedures are printed guidelines on how to use various equipment. This section has been designed for nci ccr staff to access standard operating procedures sops and sop related forms. Standard operating procedures sops ccr forms. Ccr policies and guidelines.