2010.6.18 SNUH_CTC 최정실, Oncology CRC SOPs: A Must for Sites Detailed instructions for creating strong SOPs that can serve as the backbone of studies and sites. 2010.6.18 SNUH_CTC 최정실, Oncology CRC

What are SOPs? Detailed, written instructions that specifically describe how to complete research-related activities. (who does what, where, when, why, and how) consistently execute required research-related activities improve communication among staff, reduce dependence on individuals with institutional knowledge, improve efficiency of staff training. 연구와 관련된 활동들을 어떻게 수행할 세부적인 기술한 지침 연구와 관련된 활동을 consistently 수핼할 수 있게함. Staff간의 의사소통증진, 개인과 기관의 지식에 의존함을 줄이고, staff훈련의 효율성을 증진 전세계적인 범위의 연구를 진행할 sponsor로서는 SOPs로 site seleciton 판단기준을 삼기도 함.

What to include? SOPs are intended to support compliance with laws and regulations. not necessary to document every service starting with the stated responsibilities of the investigator in ICH-GCP May add responsibilities under local laws or regulations 관련법규를 준수해야 함. 모든 서비스를 기술할 필요는 없음 IcH-GCP의 연구자 책임으로 기술된 부분에서 시작하면 됨. Local GCP나 법규의 책임사항을 더할수 있음.

How to begin? flow chart clearly and concisely written Use functional role descriptions (rather than titles or names) compliant with the laws and regulations flow chart Simplify Narratives 모든 절차는 명확하고 정확하게(해석의 여지가 없어야 함). 이름이나 title보다는 기능적역할로 명기(functional role)

Necessary features -on the first page descriptive name/title, unique identifying number(version no.) Author/Approver with dated signature Issue date Effective date Anticipated next review date Use a single format of all dates in SOP series.(DD/MMM/YYYY)

Necessary features appendices to the SOP-Associated forms, templates, flowcharts, and/or references (dated, titled, and approved ) distribution list written in the local language "SOP on SOPs." :preparation, layout, approval, control, maintenance, and implementation (including training) 부록-각종 form 배포리스트(누구에게 배포했는지) 준비, layout, 허가, 조정, 관리, 실행 등에 관한 SOP가 필요함.

Training and implementation issued prior to their effective dates allow sufficient time for training as simple as reading and understanding group instruction/discussion, one-to-one instruction, e-module instruction or other forms of training training is required for newly issued revised SOPs

Maintenance of SOPs Original SOP documents -secure location Expired original SOPs - annotated as "Archived“, retrieved for reference/ inspection, Photocopies of expired SOPs-destroyed once a new version is effective regularly reviewed and updated 효력이 지난 original SOPs는 보관으로 주를 달아놓고, 차후 inspection이나 reference가 필요할 때 꺼내서 볼수 있도록 새 버전이 효력을 발생하면 구 버전은 사진복사-> 폐기

The Standard Procedure is not Standard, Deviation documented and authorized continuously deviate from a standard operating procedure->not acceptable! The Standard Procedure is not Standard, Needs Revision! 지속적으로 일어나는 deviation-> standard가 아님.revision필요!