How a Pre-Built Form Library Changes EDC Start-Up Time

For studies that started after 17 December 2016, sponsors submitting NDAs, BLAs, ANDAs and DMFs to FDA must provide study data in the CDISC formats listed in FDA's Data Standards Catalog, including SDTM (Applied Clinical Trials). CDASH, the CDISC standard for data collection, is not in the catalog, but collecting data in a CDASH-aligned way reduces the risk and effort of mapping to SDTM later.

That requirement has a practical side effect for EDC start-up. If every study collects demographics, vital signs, adverse events and concomitant medications in the same standard way, there is no reason to design those forms again for each study. A pre-built form library turns most of an EDC build into assembly, leaving design effort for what is genuinely new.

Why build time matters

In a Tufts CSDD survey of 257 companies, the average time to build and release a study database was 68.3 days, with wide variation between companies (Wilkinson et al., Therapeutic Innovation & Regulatory Science). The same research found that releasing the full database after first patient first visit was associated with slower data entry and a longer time to database lock (Tufts CSDD release via Business Wire).

Much of that build time goes into forms that look almost the same from study to study.

Build steps with and without a library

What belongs in a form library

Most studies share a core set of forms, including informed consent, eligibility, demographics, medical history, vital signs, physical examination, adverse events, concomitant medications, laboratory results, ECG and study disposition. A useful library form carries more than its layout:

• Fields and definitions aligned with CDASH, so the meaning of each field is the same in every study.
• Controlled terminology for coded answers, consistent with SDTM.
• Standard edit checks that apply wherever the form is used, such as date logic and range checks.
• SDTM mapping defined once, so programmers do not re-map the same form for each study.
• Version history and test evidence, so the team knows which version a study used and how it was validated.

Where the time savings come from

1. Specifications shrink. Data managers specify only the forms that are new to the study, which are often the efficacy and therapeutic-area forms.

2. Build becomes assembly. Standard forms are added rather than designed, which leaves the build team free to focus on study-specific logic.

3. Testing focuses on what changed. Library forms still need testing in each study's context, but the core logic has already been tested, so most effort goes to new forms and checks.

4. Downstream work speeds up too. Consistent fields and terminology reduce queries, simplify SDTM mapping and make cross-study analysis easier.

What a library needs to stay useful

A library saves time only if it is trusted. That needs:

• A named owner, usually in clinical data management
• Change control for adding or modifying library forms
• Version numbers, with a record of which studies use which version
• Test evidence stored with each version
• Periodic review against current CDISC releases
• A rule for when a study may modify a library form, and how that is recorded
• Feedback from sites on forms that cause queries or confusion

What this means by role

• Clinical data managers: you own the library. Its quality decides how fast every future build goes.
• Clinical operations managers and directors: a library is how EDC go-live moves ahead of first patient instead of racing it.
• Quality and compliance directors: versioned forms with stored test evidence make validation and inspection easier.
• CRAs: consistent forms across studies make source data verification faster and reduce site questions.
• CRCs and principal investigators: site staff learn one way of entering common data, which means fewer entry errors and queries.

How Cloudbyz approaches this

Cloudbyz EDC is built natively on Salesforce, with a form builder, eCRFs, edit checks and query management, on the same platform as Cloudbyz CTMS and eTMF. Cloudbyz lists eCRF form library template creation, eCRF setup from the protocol, visit plan creation from the schedule of assessments and protocol reading for study setup among its EDC AI focus areas. Together these are designed to let teams start a study from library forms and the protocol, rather than from a blank build. How much time this saves depends on how much of a study's content the library already covers and on which features are enabled.

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