By Clinical Research News Staff 

September 3, 2026 | Clinical trial startup delays are often attributed to budgets, contracts, and regulatory review, but a less visible bottleneck may occur at the investigative site level: source preparation. During the latest episode of The Scope of Things, Ken Getz, executive director of the Tufts Center for the Study of Drug Development, and Rick Ward, chief commercial officer at CRIO, discussed their companies’ collaboration exploring how preparing source documents delays getting the first patient in and slows enrollment. With guest host Deena Bernstein, vice president of business development at Transformative Pharmaceutical Solutions, their conversation examined the operational challenges sites face during study startup. 

When sponsors send the protocol and supporting documents, sites must translate the study plan into usable, audit-ready data collection tools. This “protocol-guided source” work determines what staff do at each visit and what data are captured, making it an important part of study startup and data quality. It can also become a bottleneck that slows patient enrollment. Sites may receive the final protocol, investigator brochure, informed consent, CRF templates, and CRF completion guidelines, only to find inconsistencies or missing details that require back-and-forth clarification before participants can be screened. According to Getz, sites may wait five to seven weeks to receive source documents from the sponsor after being selected and engaged, creating a gap in the startup process. As a result, “site readiness” involves more than signed contracts and IRB approval; it also requires validated workflows, trained staff, and finalized source documents ready for patient visits. 

The workload can also be substantial. High-complexity trials may require more than 21 hours for a site to build, finalize, and quality-check source documents. This work is often uncompensated and competes with other site priorities, including patient care, screening, and enrollment. 

Technology may help, but electronic solutions are not universally available. Paper and hybrid workflows remain common, while eSource adoption varies among academic institutions, community sites, and large site networks. EHR-to-EDC integration is highly relevant in hospitals and large academic medical centers. Many research-dedicated sites do not have an EHR, making eSource and protocol-driven source more relevant pathways for reducing transcription and improving interoperability. 

Source preparation may fly under the radar during clinical trial startup, but its impact can extend well beyond the site. As sponsors and CROs look for ways to accelerate study timelines without compromising data quality, the source-building process may deserve a closer look. 

Hear the full conversation with Ken Getz and Rick Ward on the latest episode of The Scope of Things.