{"title":"在Navi Mumbai高等肿瘤中心对主要研究者提交继续审查申请的合规性进行审计，并对机构伦理委员会批准的有效性失误作出决定。","authors":"Bhavesh Bandekar, Kasturi Awatagiri, Sadhana Kannan, Pallavi Rane, Prafulla Parikh","doi":"10.4103/picr.PICR_102_20","DOIUrl":null,"url":null,"abstract":"<p><strong>Context: </strong>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.</p><p><strong>Aim: </strong>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.</p><p><strong>Setting and design: </strong>The present study was a retrospective audit of CRAs of ongoing projects submitted by PIs to IEC, ACTREC.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Statistical analysis: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/29/dc/PCR-13-145.PMC9345251.pdf","citationCount":"0","resultStr":"{\"title\":\"Audit of principal investigator's compliance for submission of continue review application and decisions taken on lapses in validity of approval by the Institutional Ethics Committee at tertiary oncology center in Navi Mumbai.\",\"authors\":\"Bhavesh Bandekar, Kasturi Awatagiri, Sadhana Kannan, Pallavi Rane, Prafulla Parikh\",\"doi\":\"10.4103/picr.PICR_102_20\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Context: </strong>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.</p><p><strong>Aim: </strong>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.</p><p><strong>Setting and design: </strong>The present study was a retrospective audit of CRAs of ongoing projects submitted by PIs to IEC, ACTREC.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Statistical analysis: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/29/dc/PCR-13-145.PMC9345251.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.PICR_102_20\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/2/8 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.PICR_102_20","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/2/8 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Audit of principal investigator's compliance for submission of continue review application and decisions taken on lapses in validity of approval by the Institutional Ethics Committee at tertiary oncology center in Navi Mumbai.
Context: 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.
Aim: 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.
Setting and design: The present study was a retrospective audit of CRAs of ongoing projects submitted by PIs to IEC, ACTREC.
Materials and methods: 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.
Statistical 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.
Results: 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.
Conclusion: 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.
期刊介绍：
This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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