Quality Assurance SOP Title

Friday,March 12,2010

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CRC’s conducts Clinical Research and related activities using the following SOPs . This list is not exhaustive.

#	SOP Title
1.	Research Organization and Process
2.	Research proposal
3.	Research Protocol development
4.	Research Project management
5.	Study Initiation
6.	Investigational Site setup, maintenance and closeout
7.	Research Ethics and Regulatory Considerations and Procedures
8.	Clinical Lab management setup, conduct and closeout
9.	Clinical Supplies setup, conduct and closeout
10.	Safety surveillance setup, conduct and closeout
11.	Biostatistics
12.	Study monitoring setup, conduct and closeout
13.	Medical writing and Publication
14.	Study Closeout
15.	Study Archiving
16.	Draft research proposal and submission of grant application
17.	Monitor and report research project progress and financial report
18.	Contract review and monitoring
19.	Human resource planning for the future personnel needs of CRC
20.	Advertising, selection and recruitment of job candidates, in line with the human resource plan, identified through various means
21.	Induction, Orientation and separation of Staff
22.	Plan and monitor training of All CRC staff
23.	Staff Performance appraisal & Staff promotion
24.	Planning and participation in exhibitions and conferences
25.	Document and Data Control
26.	External Audits of CRO, Vendors and Suppliers
27.	Study QA Audit
28.	Internal Audits-study process, protocols, study report, facilities etc
29.	Corrective and Preventive Actions
30.	Management of Deviations
31.	SOP training for staff
32.	ICT network administration
33.	Information Security

Last Update 04 March 2010