DOI: http://dx.doi.org/10.18203/2349-3259.ijct20193218

Maintaining electronic regulatory binder at clinical trials site improves efficiency

Hemlata Sukhija, Deepika Khanna

Abstract


Regulatory binder is one of the essential documents that is required to be maintained by all clinical sites throughout the conduct of clinical trials and post completion of clinical trials. Managing regulatory binders for multiple studies has been challenging due to large volume of documents that needs to be maintained in a paper form especially when the site has 150-200 open studies. To utilize electronic regulatory binders to replace paper based regulatory binders for improve efficiency while maintaining regulatory compliance. Use of document management system effectively allows sites to store regulatory binders electronically. Electronic regulatory binders provide a new way of managing tons of documents in a simplified fashion that helps in redefining the process, tracking documents, reducing physical storage requirements, retention, preparation for monitoring visits, and in prompt audits.


Keywords


Electronic regulatory binder, Clinical trials, Study binder, Investigator's study files

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References


E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) March 2018. https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf. Accessed on 3 January 2019.

21CFR312.57 : Recordkeeping and record retention. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.57. Accessed on 3 January 2019.

21CFR part 11, Electronic records; electronic signatures. https://www.accessdata.fda.gov/scripts/-cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11. Accessed on 3 January 2019.


Data citation

1. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) March 2018 https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf 2. 21CFR312.57 : Recordkeeping and record retention https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.57 3. 21CFR part 11, Electronic records; electronic signatures https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11