대한방사선종양학회

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학회소개

학회소개

Guidelines on the Protocol Review Committee in the Korean Radiation Oncology Group

Article 1. Name	The name of this Committee is the Review Committee (PRC) (hereinafter referred to as “Review Committee”), established under the Korean Radiation Oncology Group (KROG).
Article 2. Purpose	The purpose of the Review Committee is to review scientific evidence in studies conducted at the KROG, document and prepare a study protocol and, therefore, ensure that studies are conducted scientifically, reasonably, efficiently, and ethically.
Article 3. Principles	The purpose of the Review Committee is to review scientific evidence in studies conducted at the KROG, document and prepare a study protocol and, therefore, ensure that studies are conducted scientifically, reasonably, efficiently, and ethically.
Article 3. Principles	The Review Committee has the following principles in its operations: 1) The Review Committee reviews scientific evidence in a submitted study in an independent, reasonable, and timely manner. 2) The Review Committee should maintain independence from the influence of institutional and other specialized groups and industries in its composition, procedures, and decision-making. 3) The Review Committee should consist of individuals whose competencies and skills have been proven in their respective fields. 4) The Review Committee conducts reviews under a system that can assure and confirm reliability..
Article 4 Authority	1. The Review Committee reviews and demands the following in the study protocol: 1) Scientific evidence and justification; 2) Reasonableness for a study design based on appropriate scientific evidence; 3) Justification in statistical considerations based on a reasonable study design; and 4) Other requirements that are deemed necessary by the Review Committee. 2. The Review Committee may request the KROG to limit a study if there is any reasonable cause. 3. Any study approved by the Review Committee should obtain approval for its ethical and scientific aspects from the site’s Institutional Review Board (IRB), where the study is conducted, for the rights, safety, and welfare of participating subjects before the start of the clinical study.
Article 5 Composition	The Review Committee is composed of and operates as follows: 1) The Chair of the Review Committee is the Research Chair of the KROG. 2) Members of the Review Committee are members recommended by chair of each research division in the KROG and the Secretary of the KROG. 3) The Review Committee may have external advisors. 4) The term of a member of the Review Committee is 2 years, which may be extended. Notwithstanding the following, the term of any newly appointed member to fill a vacancy is the remaining term of the predecessor. 5) The Review Committee constitutes a quorum with the presence of more than half of its members, makes a resolution with the approval of at least two-thirds of the present members, and considers a vote to be approved if the vote count is evenly split.
Article 6 (Operating Principles)	1. Any study to be conducted through the KROG should obtain approval from the Review Committee. 2. The following documentation related to any study should be sent to the headquarters of the KROG via email (krog@ncc.re.kr) or postal mail ([10408] KROG, 1F, Cancer Prevention & Early Detection Building, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do): 1) Required documents for submission: (1) Study protocol; (2) Case report form; and (3) Informed consent form or waiver of informed consent. 2) Additional documentation for submission (if applicable): (1) Human material study information sheet and informed consent form; (2) Subject recruitment documentation; (3) Subject compensation policy; (4) Documentation about subject compensation (e.g. policy, a copy of insurance); (5) Approval letter from the Ministry of Food and Drug Safety or a competent research authority; (6) Synopsis or manual of a drug/medical device filed for approval, and a copy of the manufacture (import) marketing authorization; and (7) Study drug information. 3. Prior to filing with the Review Committee for a study the Principal Investigator wants to conduct, the Principal Investigator should discuss it in the applicable research division and then obtain approval from the Chair of that research division. 4. Upon receiving an application for review on any study, the headquarters of the KROG should consult with the Secretary, select two (2) Reviewers for any non-clinical or retrospective clinical study and three (3) Reviewers for any prospective clinical study, and make a request for review on the study protocol to Reviewers via email or postal mail under the name of the Chair of the Review Committee. To make a request, all the documentation related to the clinical study should be collated and sent. 5. Reviewers should submit review comments to the headquarters of the KROG via email or postal mail in the form determined by the Review Committee within two (2) weeks upon receiving a review request. 6. The headquarters of the KROG should send the details of a review by Reviewers to all the members of the Review Committee within one (1) week upon receiving review comments from Reviewers and proceed with a resolution. Reviewers should declare any conflict of interest and their agreement with the resolution to the headquarters of the KROG via email or postal mail within two (2) weeks. 7. A resolution on any study is divided into the following stages: approval, conditional approval, expeditious review after supplementation, re-review after supplementation, and rejection. 8. A resolution is made with the presence of more than half of the members of the Review Committee and the approval of at least two-thirds of the present members. Any member with any conflict of interest is not allowed to participate in any review and resolution on the study. 9. The headquarters of the KROG shall obtain approval for the approved study protocol and review results from the President of the Korean Society for Radiation Oncology and send an approval letter under the name of the President of the Korean Society for Radiation Oncology to the Principal Investigator via email or postal mail. 10. The headquarters of the KROG should send review comments and results about any rejected study protocol to the Principal Investigator via email or postal mail under the name of the Chair of the Review Committee. 11. The Secretary and Reviewers of the Review Committee may coordinate in advance with the Principal Investigator to revise and supplement the study protocol. If required, they may listen to advisory comments from related experts and ask the Principal Investigator to provide verbal explanations and submit supplementary documentation. 12. The headquarters of the KROG should request Reviewers to expeditiously review or re-review any re-received study protocol. A request for expeditious review or re-review should be made via email or postal mail within two (2) weeks upon receiving the protocol. 1) Documentation to be submitted for supplementation and re-review: (1) Response to review comments; (2) Documentation and table of changes proving supplementation; and (3) Revised and supplemented study protocol, case report form, and informed consent form. 2) Additional documentation to be submitted for re-review as an appeal: (1) Review request for an appeal. 13. For the study protocol re-received as a result of expeditious review after supplementation and re-review after supplementation, comments by the Review Committee should be sent via email or postal mail within two (2) weeks upon receiving a request or within three (3) weeks in case of rejection. 14. The Chair or one (1) designee should take action for conditional approval and Reviewers, while the Chair or one (1) designee should take action for expeditious review after supplementation within two (2) weeks upon receiving a request. Expeditious review after supplementation may be approved based on re-review comments submitted from Reviewers after being confirmed by the Chair or one (1) designee, and a full review may be requested if required. The Review Committee reviews re-review after supplementation and rejection. 15. If the Principal Investigator wants to directly provide an explanation about any review, the Principal Investigator may inform the Review Committee that the Principal Investigator wants to do so.
Article 7 Document Storage and Management	Documents are stored and managed by the Secretariat within 10 years. The following documents are to be stored and may be stored electronically: 1) Guidelines and standard operating procedures of the Review Committee; 2) List of members of the Review Committee; 3) Review log of the Review Committee; 4) Documents requested by the Principal Investigator; and 5) Electronic documents related to the Review Committee.
Article 8. Addendum	1. Anything not specified in these Guidelines follows common practice, and bylaws may be defined based on a resolution by the Review Committee. 2. These Guidelines will take effect upon the day when they are approved by the Board of Directors of the Korean Society for Radiation Oncology.

서울특별시 강남구 일원로 81 삼성서울병원 양성자치료센터 B2 방사선종양학과 교수실 대한방사선종양학회 (우.06351)
(06351) Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

TEL : 02-3410-3618 (사무국 대표번호) / 02-3410-3617 (ROJ 및 재무관련 업무번호)
E-mail: kosro@kosro.or.kr

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