The monitor can quickly see if documents are missing or incomplete and let the site know what they need to update within the eISF. With monitor review modules (MRMs), sites can give their monitors access to the most recent versions of their documents and data. These features make it easier for sites, sponsors, and regulatory agencies to review the most recent version of any form as well as its history. Version control and audit trails can also help CRCs keep track of when a document has been updated and who updated it. Central document linking allows clinical research coordinators to update one document and have those changes show up in every folder where the document is stored. In addition to offering Part 11 or Annex 11-compliant eSignatures, well-designed eISFs can provide features like central document linking and monitor review modules. They should be able to explain how their software follows them and provide guidance on local implementation. Fortunately, most reputable clinical trial software companies understand these regulations. To use eSignatures, sites need to make sure their eISF aligns with FDA 21 CFR Part 11, EU GMP Annex 11, and other federal or local regulations around eSignatures. The PI can then sign quickly at home, on the way to work, or in between patient appointments. Clinical Research Coordinators (CRCs) will no longer have to print or copy dozens of documents and then scan and email them to sponsors.Īnother major time-saver? Instead of driving or running across a busy hospital campus to bring paper forms to a Principal Investigator (PI), a CRC can send forms that need to be signed directly to a PI’s phone or tablet. Some eISFs may also include form templates and fillable forms that allow research professionals to create their documents entirely online. These features let sites manage their documents in real-time and generate reports and audit trails. Creating, Organizing, and Signing DocumentsĪn eISF gives sites a secure online space where they can quickly organize all of their study documents with electronic folders, placeholders, and task reminders. Well-designed software can help sites and sponsors communicate about and complete regulatory documents more quickly. Finalizing these documents via email can take weeks, especially if a site or sponsor has strict SOPs.Īn error on an informed consent document, 1572, or financial disclosure form could cause days of delays and prevent sites from opening in real time. ICH E6 (R2) regulations declare that a sponsor can’t send a clinical trial site the study drug or device until all regulatory documents are completed correctly. Speeding Up Regulatory Document Collection and Submission This is why building an integrated system is a valuable-and ultimately time-saving-part of the study start-up process. Sponsors need remote access to their sites’ documents and data, and sites need the ability to control which documents and data their sponsors can see. Sponsors and CROs can receive similar benefits by relying on electronic Trial Master Files (eTMFs) instead of paper ones.īut eISFs and eTMFs alone won’t make study start-up more efficient. An eISF will also set the site up for remote monitoring.
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