How Wingspan eTMF Solves 6 Common CRA Challenges
July 31, 2015
- eTMF Resources
Clinical Research Associates (CRAs) fill a crucial role within clinical trials, one with its own set of unique challenges. Responsible for coordinating trials across multiple areas and countries, CRAs must ensure site documents are created, submitted, and finalized accurately and in a timely manner. It is important that CRAs are able to use their clinical trial technology effectively to easily access and manage information about individual sites, studies, and documents. Wingspan recently polled a group of CRAs about their biggest challenges working within an eTMF.
1. Slow or complicated document upload process
CRAs identified document upload as a frequently cumbersome process. Since they regularly upload large amounts of documents, the process needs to be simple and fast.
Uploading documents into Wingspan eTMF couldn’t be easier. Simply drag and drop into the document placeholder. The placeholder already includes metadata such as site, country, and document due date, so you always know where it should be filed.
Many CRAs shared their struggles with inconsistent naming conventions. Without an organization-wide plan, it is impossible to find and track documents, and many times several copies are uploaded to eTMF.
While every organization needs to identify a naming convention strategy, Wingspan’s placeholder feature also eliminates many issues with naming conventions. Rather than adding a document, then naming it, users simply search for the placeholder document, then drag and drop the document they received into the appropriate location.
3. Difficulty retrieving specific documents
Searching for specific documents is easy with Wingspan eTMF’s Quick Search tool and Document Search Tab. The Quick Search tool allows you to type the name of a document or related term. It pulls up a complete list of documents containing or associated with the entered phrase.
The Document Search Tab allows you to create a custom document list. Designed to resemble an online shopping experience, it is easy to click and choose your search criteria. You begin with a full set of documents and document placeholders, which are narrowed down as you make selections in the Document Search Tab.
4. Tracking the progress of individual sites
By creating placeholders for every eTMF document at the beginning of a trial, it is easy to track the progress of individual studies and sites. Continuously throughout the study, Wingspan eTMF tracks the completeness, quality, and timeliness of your clinical trial. It is easy to drill down for more specific metrics such as which sites or countries are falling behind, what documents are frequently late, and which types of documents have the most mistakes.
The User Homepage also features a Site Dashboard, which provides insight into the status of each of site assigned to the user. Here, the CRA can instantly view the timeliness, completeness, and quality levels for each of his or her sites. It also displays each site’s most recently reached milestone and the number of documents coming or past due.
5. Collecting and storing wet ink signature documents
Collecting, scanning, uploading, and storing documents containing wet ink signatures becomes a burdensome process for CRAs, and it adds to the overall cost and length of a clinical trial. Wingspan’s e-signature feature helps reduce the burden of paper documents. Rather than email or ship signed documents back and forth, eTMF users can sign documents right in eTMF. SiteZone, our site-level solution, also extends this feature for use at the clinical sites, allowing any site document designated by the sponsor or CRO to be signed electronically and immediately pushed into eTMF. In addition to reducing paper flow and travel to sites, this eliminates the need to store documents containing wet ink signatures.
6. Missing and/or incomplete documents during inspection
Wingspan eTMF’s completeness, timeliness, and quality reports make it easy to constantly track your level of inspection readiness. Thanks to the placeholder documents, you always know which documents are coming or past due, so you can follow-up with individual sites. Customizable reports allow you to drill down and identify specific bottlenecks within the process.
Though CRAs may have been neglected in earlier eTMF solutions, their feedback is becoming more and more important as the technology grows. Making CRAs, and all users, more productive within eTMF will have significant impact on the overall health and efficiency of an organization’s eTMF.