Should screen failures be counted?

Count them if screen-failed participants get CRF pages in your EDC. Estimate screened participants with screening forms only, then add that to the count for enrolled participants.

Why does the SDV share matter so much?

It multiplies the largest count in the study, the data points. Moving from verifying every field to verifying critical data only cuts SDV fields in the same proportion, so the monitoring plan deserves a decision before the build starts.

Who builds the EDC once the numbers are known?

Agnotic Technologies builds custom EDC, CDMS and eCOA software for sponsors and CROs, with Part 11 audit trails and HIPAA-ready engineering designed in. Timelines depend on scope; we agree a fixed first release on the scoping call.

Can eCOA and IRT data flow into the EDC?

Yes. Agnotic builds transfers from eCOA and IRT or RTSM systems into the study database, following the data transfer agreements set for your study.

Do you build to CDISC standards?

Yes, where the sponsor requires it. We build collection forms to CDISC CDASH so the collected data traces into SDTM.

An empty clinical data office desk with two monitors, a desk lamp and a chair beside a window at dusk

Software we build

Clinical trials data volume: what a protocol creates and what we build

A protocol's schedule of assessments decides how many visits, CRF pages, data points, queries and fields to verify a study generates. Agnotic Technologies builds EDC, CDMS and eCOA software to your protocol and requirements, sized from those figures.

15-Minute Scoping Call See what we build

Last reviewed October 21, 2026 by the Agnotic Technologies engineering team

How much data will a clinical trial generate?

A clinical trial's data volume follows from its sites, participants, visits, forms per visit and fields per form, plus any eCOA entries. Each data point needs an edit check, an audit trail entry and possibly source data verification. Agnotic Technologies builds EDC, CDMS and eCOA software sized from the protocol's schedule of assessments.

Which problems does trial data volume create?

Every field a protocol adds is multiplied across sites, participants and visits. These are the problems that follow.

Fields no endpoint uses
Each field adds an edit check, audit trail entries and possibly SDV work. Fields that no endpoint or safety review uses inflate every later task.
Audit trails that grow with every change
21 CFR 11.10(e) requires time-stamped audit trails for every entry that creates, modifies or deletes a record, kept as long as the record. That shapes storage, query speed and review screens.
Query backlogs before database lock
Query volume rises with data points. Without site response tracking, data managers lose sight of open queries as lock approaches.
Monitoring plans that exceed CRA capacity
Verifying every field can exceed what CRAs can cover in planned visits. ICH E6(R3) allows centralised monitoring to reduce the extent of site monitoring.
Missed eCOA entries
Diaries and questionnaires completed by participants need device sync, missed-entry alerts and a clean transfer into the EDC.
Amendments that change the counts
A protocol amendment changes forms and visits mid-study. Without versioned designs, its effect on data volume is hard to compare.

What do we build for trial data?

Agnotic Technologies builds trial data software to your protocol and requirements, for sponsors, CROs and research sites. These are the features we typically build.

eCRF design from the schedule of assessments
Forms, visit windows and scheduling rules built from the protocol, using CDISC CDASH collection formats where the sponsor requires them.
Edit checks and query workflow
Field and visit-level checks that raise queries, with site response tracking and data management dashboards through to closure.
Part 11 audit trail
Computer-generated, time-stamped records of every create, modify and delete, with review screens built for the expected data point count.
Risk-based SDV flags
SDV marked per field, so the monitoring plan can verify critical data on site and send lower-risk fields to centralised review.
eCOA capture and transfer
Diaries and questionnaires on site devices or participants' phones, with missed-entry alerts and transfer into the EDC.
Protocol version control
Form and visit designs versioned with each amendment, so changes and their effect on the data can be compared line by line.
Exports toward SDTM
Casebook and dataset exports, with CDASH-collected data mapped toward SDTM datasets for analysis and submission work.

How do you estimate a trial's data volume?

Work from the current protocol version and the schedule of assessments. Five steps give the main counts.

Take active sites and planned participants per site from the enrolment plan. Use the planned figure, not the screened one, unless screen failures also get CRF pages in your EDC.
Count scheduled visits per participant from the schedule of assessments, including screening and follow-up visits that collect data. Count unscheduled visits separately if they are common in your indication.
Multiply visits by eCRF forms per visit and fields per form. A form is one CRF page in the EDC; a field is one value a site enters or a device sends.
For eCOA, multiply diary or questionnaire entries per week by the weeks each participant stays on study. How those entries are captured is covered on our eCOA software development page.
Apply your own query rate and SDV share, from a past study or the draft monitoring plan.

Which part of the EDC build does each figure size?

Each count lands on a different part of the trial system and a different team.

If you license a commercial EDC, check how its tiers count studies, pages or records before you compare offers, so the right figure goes into each comparison.

The query workflow itself, from edit check to closure, is covered on our clinical trials CDMS and EDC development page.

Study data figures and what they size
Figure	What it sizes in the build	Who works with it
Total visits	Visit windows, scheduling rules and visit-level edit checks	Data management and site staff
CRF pages	eCRF design work, page-level signatures and the size of the casebook export	Data management and investigators
Data points	Database size, edit check load and the audit trail, since every entry and change is recorded	Engineering and quality
Expected queries	Query workflow capacity, site response tracking and data management dashboards	Data managers and CRAs
eCOA records	Device sync volume, missed entry alerts and the eCOA to EDC transfer	eCOA build team
SDV fields	Monitoring plan scope, SDV flags per field and CRA visit planning	Clinical operations

Why does the data point count matter most?

Data points multiply every later quality task. Each value needs an edit check decision, a place in the audit trail and, if it is flagged for SDV, a monitor's time.

21 CFR Part 11 asks for computer-generated, time-stamped audit trails for every entry that creates, modifies or deletes an electronic record, kept as long as the record. More fields per form means a larger audit trail, which shapes storage, query speed and the audit trail review screens your team will use.

Removing fields that no endpoint or safety review uses is the change that shrinks every other count at once.

What should you do with the counts?

Share the counts with your EDC or CDMS build team so forms, edit checks and the audit trail are sized from the same numbers.
Test the monitoring plan with the SDV field count. If it is more than CRAs can verify in the planned visits, move lower-risk fields to centralised review.
Estimate twice, with and without optional assessments, to see what each assessment adds.
Count protocols with a heavy baseline and light follow-up visits per visit type, not with one average.
Allow for screen failures, early terminations, unscheduled visits and repeat labs, which change the real totals.
Keep the figures with the protocol version, so an amendment can be re-estimated and compared line by line.

How does Agnotic build trial data software?

Agree on a scoping call the protocol version, the schedule of assessments and which systems feed the study database.
Size forms, edit checks and the audit trail from the visit, page and data point counts.
Build the eCRFs, query workflow and SDV flags, with eCOA and IRT connections where the study needs them.
Test the system against your requirements before first participant in, and version the designs for each amendment.

Facts and sources

Which rules and standards shape trial data volume?

Short facts we design trial data systems around, each linked to its primary source.

21 CFR 11.10(e) requires secure, computer-generated, time-stamped audit trails that record operator entries and actions that create, modify or delete electronic records, kept for at least as long as the records themselves.
Source: 21 CFR 11.10 (eCFR)
ICH E6(R3), adopted on 6 January 2025, lists source data review and source data verification among monitoring activities and says the monitoring approach should be included in the monitoring plan.
Source: ICH E6(R3) Guideline for Good Clinical Practice (ICH)
ICH E6(R3) says centralised monitoring can complement and reduce the extent or frequency of site monitoring, or be used on its own.
Source: ICH E6(R3), section 3.11.4.2 (ICH)
CDISC CDASH establishes a standard way to collect data consistently across studies and sponsors, with collection formats that trace into the Study Data Tabulation Model (SDTM).
Source: CDISC CDASH