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2. 2 KEMRI-Wellcome Trust Research Programme STANDARD OPERATING PROCEDURES

3. SOP Definition 3Ken Awuondo KEMRI-Wellcome Trust Research Programme Standard Operating Procedures- documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines Detailed, written instructions to achieve uniformity of the performance of a specific function- ICH GCP E6 1.5.5

4. Functions of SOPs 4Ken Awuondo KEMRI-Wellcome Trust Research Programme Establish standard procedures which will ensure quality and integrity of the data To leave a permanent record of the methodology employed To communicate these procedures to those who will undertake them and underpin training SOPs are the way in which we set standards

5. SOP Requirement 5Ken Awuondo KEMRI-Wellcome Trust Research Programme Management: – Ensure appropriate SOPs are established – Approve all original and revised SOPs – Ensure maintenance of historic file of all SOPs – Current versions available and Amendments documented – Should contain sufficient detail to provide clear instruction to staff

6. SOP Requirement 6Ken Awuondo KEMRI-Wellcome Trust Research Programme Personnel: – Have access to appropriate SOPs – Responsible for complying with SOPs instructions – Communicate and document to responsible person any deviation from SOP instruction

7. SOP System 7Ken Awuondo KEMRI-Wellcome Trust Research Programme Documented Approved Controlled Reviewed periodically: take time to look at the process… Effective date Historic versions retained Amendments documented

8. SOP System 8Ken Awuondo KEMRI-Wellcome Trust Research Programme SOP To cover areas such as: – Format, control and review of SOPs – Sample handling- receipt, chain of custody, storage, repeat analysis, etc – Methods or control of methods – Equipment use and maintenance – Record keeping – QC procedures – Audit procedures

9. SOP tracking 9Ken Awuondo KEMRI-Wellcome Trust Research Programme Numbering System: Example LCHEM 01 Distribution: Electronic/paper Retiring SOPs

10. Who should write SOPs 10Ken Awuondo KEMRI-Wellcome Trust Research Programme Someone who understands the procedure Use specified format

11. Changing of SOPs 11Ken Awuondo KEMRI-Wellcome Trust Research Programme Within defined periodic reviews An SOP can be changed at any time You should not implement a new practice until the SOP has been updated New version issue

12. SOP training Core of the staff training programme Significant changes should result in training SOP training- training should be focused on the process Ken Awuondo12 KEMRI-Wellcome Trust Research Programme

13. Common Problems with SOPs 13Ken Awuondo KEMRI-Wellcome Trust Research Programme Missing SOPs SOPs are not followed SOPs do not reflect current practice Current revision of an SOP is not the one being used Unofficial copies of SOPs are used Contradictory SOPs

14. THANK YOU ANY QUESTION? Ken Awuondo14 KEMRI-Wellcome Trust Research Programme