Clinical Research Sop Template Free
Sop 501 case report forms.
Clinical research sop template free. Sop 504 archiving study records. 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. Standard operating procedures sops are uniformly written procedures with detailed instructions to record routine operations processes and practices followed within a business organization. Conducting the study in accordance with the irb approved protocol as it is written.
Ccr policies and guidelines. Dghi is pleased to share these documents with others who are working in resource limited locations. Sop 405 study visits. Use a training log to record all training that the site study staff completes signing the log entry for.
Sample user standard operating procedure version. Sop 406 payments to subjects. And the hiring training and retention of coordinators and other site personnel. Protocol and gcp compliance.
To share your own templates and sops or comment on these please. Standard operating procedures are printed guidelines on how to use various equipment. Nci ccr standard operating procedures sops related forms policies and guidelines. Sop 404 protecting confidentiality of study subjects.
Protocol deviation reporting and documentation. Sop 503 electronic records. Sop 505 printing and certifying medical records. Sop 602 fda audits.
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. 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. 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 601 quality control.
This section has been designed for nci ccr staff to access standard operating procedures sops and sop related forms. Nih human research protection program hrpp nih hrpp sops. The principal investigator is responsible for. Standard operating procedures sops ccr forms.
The clinical trials unit at kilimanjaro christian medical center has prepared numerous standard operating procedures sops for clinical trials that meet nih requirements. Focus on improved data quality. Clinical trial site operations templates and sops conducting clinical trials and building a high capability coordinator team. Sop 502 source documentation.
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