Continuing Review
POLICY
beplay苹果手机能用吗最初由召集的IRB审查和批准的研究必须以适合风险程度的间隔进行审查和批准，但每年不少于一次。确定批准期限是在初次审查或先前持续审查时进行的。只要研究保持活跃，就需要继续进行审查。beplay苹果手机能用吗
For studies initially reviewed by a convened IRB, continuing review will no longer be required when the activities that remain for the study are eligible for review by expedited procedure in accordance with CPHS policy on expedited review; or research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
For research studies initially reviewed and approved by expedited review, continuing review is not required, unless the IRB reviewer determines that continuing review would enhance protection of research subjects.
PROCEDURE
Reminders for Continuing Review Submission: IRB outcome letters state the expiration date at initial review and subsequent continuing reviews. Automatic email reminders are sent by iRIS to the Principal Investigator 120, 90, 60 and 30 days prior to the expiration date. For studies that do not require continuing review, outcome letters will not have an expiration date. However, a letter will be sent before the one year anniversary date to remind Principal Investigators to request an update on the study status and remind them to submit to the IRB any protocol amendments, adverse events, protocol deviations, personnel changes, conflicts of interest, and any other type of reporting.
Submission- 首席调查员必须通过IRIS完成并提交持续的审查申请。持续的审查申请应包括：
有关研究进展的状态报告包括：beplay苹果手机能用吗
- Number of participants accrued.
- 自上次IRB评论以来的摘要：
- Adverse events, untoward events, and adverse outcomes experienced by participants.
- 意外的问题涉及参与者或其他人的风险。
- Participant withdrawals.
- The reasons for withdrawals.
- 关于这项研究的投诉。beplay苹果手机能用吗
- 修订或修改。
- Any relevant recent literature.
- 任何临时发现。
- 任何相关的多中心试验报告。
- 根据研究beplay苹果手机能用吗结果，研究人员当前的风险潜力福利评估。
- 有关圣udy related documents, including but not limited to, reprints of articles, deviation log, etc.
- CPHS可能要求的任何其他文档。
分配审查–IRB staff will screen the submission to assess if the information is adequate. If the information is not adequate, IRB staff will request additional information from the Principal Investigator. Once adequate information is obtained, IRB staff will determine if the continuing review may be reviewed by expedited review or Full Board review.
Research studies reviewed by expedited procedure do not require continuing review. The expedited reviewer may require continuing review if it would enhance protection of research subjects. If continuing review is required for these studies, the expedited reviewer must explicitly justify and document why continuing review would enhance protection of research subjects. IRB staff will assign the continuing review to the same reviewer that initially reviewed the proposal, if possible. If the reviewer determines that the continuing review does not qualify for expedited review, the IRB staff will assign the submission for Full Board review.
For research initially reviewed and approved at a convened IRB, IRB staff will schedule the continuing review for the next available Full Board meeting of the same IRB panel that initially reviewed the research project. IRB staff shall assign the submission to the chair of the subcommittee that initially reviewed the research. If the chair is not available, IRB staff will assign it to one of the other subcommittee members or another IRB member.
审查过程- IRB members, including the assigned reviewer, have access to the continuing review submission and all study documents previously submitted and approved. All members are expected to review at least the continuing review submission.
When conducting continuing review, the IRB starts with the working presumption that the research, as previously approved, satisfies all of the criteria for approval. The IRB review focuses on whether there is any new information provided by the investigator, or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects. The IRB also assesses whether there is any new information that would necessitate revision of the protocol and/or the informed consent document. When conducting continuing review and evaluating whether research continues to satisfy the criteria for IRB approval of research, the IRB review will pay particular attention to the following four aspects of the research:
- Risk assessment and monitoring;
- Adequacy of the process for obtaining informed consent;
- Investigator and institutional issues; and
- Research progress.
When the study is part of a multi-center trial or when a study subject to oversight by a DSMB, the CPHS may rely on a current statement from the DSMB or sponsor indicating that it has reviewed study-wide adverse events, interim findings, and any recent literature that may be relevant to the research.
Verification from Other Sources: CPHS may determine that the study needs verification from sources other than the investigators that no material changes had occurred since previous CPHS review. CPHS may seek verification from sponsor, study coordinator, monitoring by Clinical Research Monitor, external audit etc. Some of the situations where verification could be considered appropriate are:
- Investigators who do not have a proven track record,
- Investigators who have had problems in the past,
- 具有复杂设计的研究
- 第一阶段研究，
- 研究人员开始了临床试验，
- beplay苹果手机能用吗涉及对象的高风险的研究；
- 特别复杂的程序或干预措施；
- Potentially vulnerable populations;
- Study staff with minimal experience in administering consent to potential subjects; or
- Other situations where CPHS has concerns.
可能的结果of Review– CPHS may decide to approve, approve pending, defer, disapprove or table the continuing review as per policy and procedure Initial Review. For continuing reviews approved by the Full Board, the approval date is the date of the meeting. For continuing reviews approved by expedited review, the date of approval is the date of the review. CPHS may approve the research for a period of one year or less as described in the policy and procedure Initial Review.
结局的交流：IRB工作人员将及时通知首席调查员通过IRIS的审查结果。IRB的工作人员将包括一份持续的评论清单，该审查在下一次完整董事会会议的议程中加急审查批准。
过期的研究 -When continuing review of a research protocol does not occur prior to the end of the approval period specified by the CPHS, CPHS approval expires automatically. There isno grace period将研究的行为扩展到CPHS批准的到期日期。beplay苹果手机能用吗CPHS批准的到期将不会向OHRP报告，以暂停CPHS批准。beplay苹果手机能用吗
After the date of expiration, the IRB staff will send a formal notice of termination of the study approval to the Principal Investigator, with the instructions that enrollment of subjects and all research related procedures must be stopped.
如果通过停止研究程序将损害已经参加研究的患者的安全和福祉，则首席研究员必须与执行主席或指定人员联系。执行主席或指定人员可以允许继续并指示首席调查员提交持续的审查文件。IRB工作人员将在下一次可用会议上放置CPHS审查beplay苹果手机能用吗研究研究。
研究完成：研究完成后，PI应在研究完成后30天内提交研究完成报告。完成报告应使用研究关闭报告提交。
IRB staff will review the Study Completion report and obtain any outstanding information or documentation from the Principal Investigator. If there are inconsistencies or if clarification is needed, IRB staff will request for additional information.
IRB工作人员将审查记录，以确保所有文档完成，并表明该研究已在IRIS的研究文件上完成。
APPLICABLE REGULATIONS
- 45 CFR 46保护人类受试者
- 21 CFR 50 Protection of Human Subjects
- OHRP Guidance on Continuing Review
- FDA Information Sheet: Continuing Review After Study Approval
REFERENCES TO POLICIES AND PROCEDURES
- Initial Review
- 加急评论
附件
- Continuing Review Form
- Continuing Review – Approval Letter
- Continuing Review – Approval Pending Letter
- Continuing Review – Expired Letter
- Study Closure Report
If you find errors in this document, contactcphs@uth.tmc.edu
Document Number: |
101-C04 |
文档名称： |
Continuing Review |
Reviewed by: |
Executive Director, Research Compliance |
Effective: |
1 Aug 2008 |
Revision History: |
1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 19 July 2018, 1 Jun 2021, 1 Sept 2021 |
CPHS求助热线713-500-7943
Iris Holpline 713-500-7960
Uthealth的合规性热线（1-888-472-9868）
保护人类受试者委员会 IRIS Support713-500-7960 |
|
|
CLINICAL TRIALS RESOURCE CENTEROFFICE OF RESEARCHENVIRONMENTAL HEALTH & SAFETY |
||
