Database Build Standard Timeline from Final Protocol to Database Go-Live

Database build sits on the critical path between protocol finalization and first patient in. Especially for studies pursuing a rapid start-up period, database builds must be completed and undergo a robust quality review in a timely manner so as not to delay study conduct.

At PharPoint, our standard timeline for a database to go-live is typically 6-8 weeks.

Below, we break down this timeline and outline the approach used by our data managers and database programmers to ensure the design of a high-quality database.

Beginning with eCRF Production

Upon receipt of a finalized protocol, PharPoint’s data management team works closely with our database programming team to begin building electronic case report forms (eCRFs).

eCRFs are digital – typically web-based – protocol-driven questionnaires used to collect specific study data during a clinical trial. The primary purpose of eCRF design is to preserve and maintain the quality and integrity of data. CRFs must be designed to address the needs of all users, including site coordinators, monitors, data managers, and study biostatisticians.

At PharPoint, eCRFs are typically produced, internally reviewed, and delivered to the client for their review and approval in 10 business days, depending on protocol complexity.

One unique aspect of PharPoint’s workflow is how we approach initial eCRF development and review. Rather than providing a spreadsheet of specifications for eCRFs, PharPoint’s team programs the unique CRFs upfront and delivers them with annotations for sponsor review and approval. We have found this approach helps streamline review by providing sponsors with a more intuitive sense of how the final product might look.

For a typical project, a lead database programmer is assigned as the build’s primary architect. The lead programmer can build unique eCRFs from the ground up, but they also know PharPoint’s standard CRFs inside and out. This ensures time and effort is not lost rebuilding what already works.

Ensuring high-quality eCRFs

As individual unique screens are finalized by the programmer, they can be passed in batches to the data management team for a full review and user acceptance testing. This batched review allows us to accelerate our timeline without sacrificing quality.

Outside of data management review, eCRF production often includes collaboration with biostatisticians and clinical operations teammates. A database has multiple end users, and this collaboration ensures all unique end goals are considered during database design.

Once reviewed by our internal team, unique eCRFs are passed to the client for their review and approval.

Finalizing database functionality

Following the full approval of unique eCRFs, our team begins building visit structure and database structure. This, again, is reviewed by our team in a full user acceptance testing prior to being delivered to the client for review.

For studies without complex integrations or external vendor dependencies, our team completes this entire process in 5 business days.

At this point, screens and the structure and functionality of the database are complete.

Developing Custom Edit Checks

Edit checks are automated processes that draw attention to data that are inconsistent or potentially erroneous – for instance, data that are missing, out of range, or discrepant with other data or study parameters. Well-designed edit checks are an invaluable tool for increasing data management efficiency and overall data quality.

The study’s lead data manager begins working on the development of custom edit checks following the finalization of eCRFs, starting with specifications.

While a typical study has somewhere around 400 edit checks, this number can range significantly, as it is not uncommon for complex studies to have upwards of 1,000.

Specification planning relies on multiple sources of information, including:

• The study protocol,
• The data management plan,
• Finalized eCRFs, and
• Collaboration with other functional experts, such as biostatisticians and clinical operations teammates, who can proactively identify fields that may be particularly prone to error.

Once edit check specifications have been approved by the sponsor team, programming begins. At PharPoint, edit check programming and user acceptance testing is completed in approximately 12 business days.

At this point, the database is ready for final sponsor approval and go-live.

Work with PharPoint for database design and development

PharPoint is a contract research organization (CRO) built for collaboration, with deep experience providing biometrics CRO support for sponsors of all sizes.

To learn more about the PharPoint team, our experience, and how our data management team can help you build a high-quality database for your upcoming study, reach out.