6 Places Site Staff Duplicate Work, and How eSource Removes Them

Sites typically have six or more different logins per study, and a typical oncology study can require the site's own systems plus as many as 17 more (DIA Global Forum). Over 60% of sites use more than 20 applications daily, and in a Society for Clinical Research Sites survey, sites said they want integrated systems that work across sponsors and trials (MedCity News).

Each extra system usually means the same fact is recorded more than once. Re-entering data into EDC is the best-known example, but it is only one. The six places below are where coordinators and investigators most often do the same work twice, and how eSource, used as the site's working record, takes the second copy away.

Duplicate work across one study visit

1. Visit scheduling

Coordinators often schedule a visit in the clinic calendar, update a study tracker and then report it to the sponsor. When eSource holds the visit schedule built from the protocol, with the allowed window for each visit, the schedule is set once and the window is visible before the patient is booked.

2. Informed consent

Consent is frequently documented on the signed form, again in a progress note, and again in a consent log, with the version tracked by hand. eConsent records the version, date and signature in one place, which also makes it easier to check that the current version is in use.

3. Visit procedures and data

The best-known duplication is recording vitals, labs and assessments on a paper worksheet and then typing them into the eCRF. With eSource, the visit template follows the schedule of assessments, the data is entered once, and it can be shared with the study database.

4. Adverse events

An adverse event can be written in the source note, added to an AE log, entered in the eCRF and, if serious, reported again on an SAE form. Recording it once and sharing it with the eCRF and the safety record reduces both the effort and the risk of the copies disagreeing.

5. Delegation logs and training records

Delegation logs, CVs and training certificates are often kept on paper in the investigator site file, then uploaded again to sponsor portals. An eRegulatory record that sponsors can view, rather than receive copies of, removes the second upload.

6. Visit payments

Sites track completed visits to invoice the sponsor, then reconcile the payment when it arrives. Linking completed visits to the contracted site budget means the payable amount is known as soon as the visit is done.

Site checklist for reducing duplicate work

• List every place each visit, consent, AE and log entry is recorded today
• Decide which system is the source for each, and write it in the source data plan
• Confirm the eSource visit templates match the current protocol version
• Check which fields are shared with the sponsor's EDC and which still need entry
• Agree with sponsors or CROs to view eRegulatory records rather than receive copies
• Link visit completion to the site budget for invoicing
• Review the list each quarter as new studies start

What this means by role

• CRCs: fewer copies of the same information, fewer reconciliations, and more time with patients.
• Principal investigators: one place to review and sign data, consent and AEs, with a clear audit trail.
• Site directors and site networks: less duplicate work makes each new study cheaper to run and easier to staff.
• CRAs: fewer discrepancies between copies to find and query at monitoring visits.
• Sponsors and clinical operations directors: studies that ask less of sites are easier to place with experienced sites.

How Cloudbyz approaches this

Cloudbyz offers a set of products for clinical sites, SMOs and site networks, built natively on Salesforce. According to Cloudbyz product materials, Cloudbyz eSource covers visit management, eConsent, eCRFs, demographics, medical history and vital signs, AE and protocol deviation capture, lab reports, query management, device integrations and export of data to EDC. On the same platform, site CTMS covers appointments, visit schedules, subject management, budgets and payments, and eRegulatory covers the investigator site file, delegation logs, SOPs and IRB approvals, with portals for sponsors and CROs. Because these share one platform, a visit, consent or AE recorded once can be used across them. How much duplication this removes depends on which products a site uses and how each study is configured.

Frequently asked questions

What is eSource for research sites? A research system where site staff record study data, consent and visit information electronically at the point of collection, so the electronic record is the source.

How does eSource reduce duplicate work? By making one record the source for each visit, procedure, consent and AE, and sharing it with other systems rather than re-entering it.

Is eSource only about EDC data entry? No. Removing re-entry into EDC is the best-known benefit, but eSource can also remove duplicate scheduling, consent logs, AE logs and regulatory uploads when it is connected to the site's other systems.

See a site visit recorded once

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