Bandekar Bhavesh, Awatagiri Kasturi, Kannan Sadhana, Rane Pallavi, Parikh Prafulla
Advanced Centre for Treatment, Research and Education in Cancer, Tata Mémorial Centre, Navi Mumbai, Maharashtra, India.
Epidemiology and Clinical Trial Unit, Advanced Centre for Treatment, Research and Education in Cancer, Tata Mémorial Centre, Navi Mumbai, Maharashtra, India.
Perspect Clin Res. 2022 Jul-Sep;13(3):145-150. doi: 10.4103/picr.PICR_102_20. Epub 2021 Feb 8.
A failure to obtain continued Institutional Ethics Committee (IEC) approval for the study before the expiry date assigned by the IEC is considered as "lapse of the IEC approval" to continue the study at the site by the Investigator. Considering this, we had conducted an audit of principal investigators (PI ') compliance for Continuing Review Application (CRA) submission timelines and decision taken on the lapses in the validity of IEC approval continuation.
The aim of this study is to assess the pre- and post-policy trends of non-compliance management of delayed CRA submission and compare the PI's compliance for submission of CRA between Investigator Initiated trial (IIT) and Pharma studies.
The present study was a retrospective audit of CRAs of ongoing projects submitted by PIs to IEC, ACTREC.
The data from total 199 CRAs submitted for review to the IEC between the year January 2016 and December-2017 were collected and maintained in Microsoft Excel sheet, and later, the data were exported into the SPSS software version 21 for the analysis.
All categorical data were presented in numbers and percentage. The first primary objective was assessed by calculating the duration between the dates of approval for any study to the date of next CRA submission. The CRAs submitted after the project expiry date were considered as a lapse in following the IEC SOP.
This retrospective audit revealed that CRA reminder sent by the IEC to the PI played an important role in compliance w. r. t timely in following the IEC SOPof the CRA by the PI. As a result, overall, 90% of CRAs showed compliance in submitting CRAs to IEC in both IIT and Pharma study. The number of lapses were reduced to 7 in the postpolicy period as compared to 15 lapses in the prepolicy period.
This retrospective audit reveals that CRA reminder sent by the IEC to the PI played an important role in improving the compliance of PIs in submitting CRA to IEC. Each IEC should develop the policy to minimize the delays in CRA submission by the PI and prevent lapses in following the IEC SOP.
如果在机构伦理委员会（IEC）指定的到期日期之前未能获得该委员会对研究的持续批准，调查员会认为这是在该研究地点继续研究的“伦理委员会批准失效”。考虑到这一点，我们对主要研究者（PI）提交持续审查申请（CRA）的时间合规性以及针对伦理委员会批准延续有效性失误所做的决定进行了审核。
本研究的目的是评估延迟提交CRA的违规管理在政策实施前后的趋势，并比较研究者发起的试验（IIT）和制药公司研究中PI提交CRA的合规情况。
本研究是对PI提交给ACTREC伦理委员会的正在进行项目的CRA进行的回顾性审核。
收集了2016年1月至2017年12月期间提交给伦理委员会进行审查的总共199份CRA的数据，并保存在Microsoft Excel工作表中，随后将数据导出到SPSS 21软件版本中进行分析。
所有分类数据均以数字和百分比表示。第一个主要目标是通过计算任何研究的批准日期到下一次CRA提交日期之间的时长来评估。在项目到期日期之后提交的CRA被视为未遵循伦理委员会标准操作规程（SOP）的失误。
这项回顾性审核显示，伦理委员会向PI发送的CRA提醒在PI及时遵循伦理委员会CRA的SOP方面发挥了重要作用。结果，总体而言，在IIT和制药公司研究中，90%的CRA在向伦理委员会提交CRA方面表现出合规性。与政策实施前的15次失误相比，政策实施后失误次数减少到了7次。
这项回顾性审核显示，伦理委员会向PI发送的CRA提醒在提高PI向伦理委员会提交CRA的合规性方面发挥了重要作用。每个伦理委员会都应制定政策，尽量减少PI提交CRA的延迟，并防止在遵循伦理委员会SOP方面出现失误。
