Clinical Trial Startup Workflow Checklist: Site Activation Guide

The gap between "protocol finalized" and "first patient enrolled" is where clinical development loses the most time. The National Cancer Institute recommends a 90-day activation target, yet anecdotal data from NCI-designated cancer centers in 2024 show actual times ranging from 78 to 313 days depending on the institution ^[1]. Across all therapeutic areas, WCG data covering Phase I-III trials over the past three years places the median activation time at 9.4 months for academic medical centers and hospitals ^[2]. That spread is not random. It reflects differences in how rigorously each startup phase is planned, sequenced, and tracked.

A structured clinical trial startup workflow checklist is among the most straightforward tools available to reduce that spread. Not because a checklist solves the underlying complexity of multi-party clinical operations, but because most startup delays are not failures of expertise. They are failures of coordination: tasks that started late because no one verified a prerequisite was complete, documents that held up contracting because the wrong version was distributed, or training that was scheduled before IRB approval arrived. This article provides a phase-by-phase operational checklist, grounded in current regulatory expectations and published evidence on where startup time is gained and lost.

Why Startup Timeline Performance Matters More Than Teams Often Acknowledge

Site activation delays have direct and measurable consequences for both trial success and patient access to investigational therapies. A 2025 study by researchers at the University of Kansas Cancer Center, published in Contemporary Clinical Trials Communications, found that studies reaching the 70% accrual threshold had a median activation time of 140.5 days, compared with 187 days for studies falling short of that threshold ^[7]. Faster activation, in other words, is not just an operational metric. It is associated with trial success.

The cost dimension is similarly concrete. A 2024 analysis by Smith, DiMasi, and Getz at the Tufts Center for the Study of Drug Development, published in Therapeutic Innovation and Regulatory Science and summarized in the Tufts CSDD white paper, found the mean direct cost to conduct a Phase III trial at $55,716 per day on average in 2023 USD, based on budgets from 447 protocols ^[3]. That figure is a whole-trial average, not attributable to any single site, but it frames why every week a study is delayed in activation carries real direct cost consequences at the program level.

The causes of these delays are well-documented. WCG's 2025 Clinical Research Site Challenges Report, drawing on a survey of sites worldwide, identifies contracts and budgets as a major driver of study startup delays, with the challenge persisting across multiple annual survey cycles ^[4]. WCG's own budget benchmarking data shows that US sites report an average of 52.5 days from budget receipt to finalization, with the average contract timeline including negotiation running approximately 63.8 days, and WCG notes that negotiations have never taken longer ^[5]. A 2023 study published in the Journal of Clinical and Translational Science found that average contract negotiation duration exceeded 100 days for industry-sponsored or investigator-initiated contracts under the CTSA Contracts Processing Study framework ^[6]. The same analysis demonstrated that use of standardized templates substantially shortened those timelines: the Accelerated Clinical Trial Agreement (ACTA) saved an average of 48 days, and the FDP-CTSA template saved an average of 57 days of negotiation ^[6].

These are operational losses with recoverable solutions. The checklist structure below maps each phase against the specific tasks where delays most commonly accumulate.

Startup Phase Summary: Key Milestones and Typical Sequencing

Phases 2, 3, and 4 can run in parallel after feasibility is complete. The SIV and all screening activities are hard dependencies: neither can begin before IRB approval and CTA execution are both confirmed. Whether IRB approval must formally precede CTA execution varies by institution; many academic medical centers require it, while some sites permit parallel processing. Confirm this sequencing with each site's research office early in the startup process.

Phase 1: Feasibility and Site Selection

Operational Assessment Before Site Outreach

The feasibility phase sets the trajectory of startup. Selecting sites that appear qualified but lack the operational infrastructure to execute creates problems that no amount of post-selection remediation resolves efficiently. ICON data from pharmaceutical and biotech studies between 2021 and 2023 showed site pre-selection decline rates rising from 35% to 47% across that period ^[8], a signal that initial site assessments were frequently overestimating operational readiness.

Feasibility checklist at the sponsor or CRO level:

• Protocol synopsis finalized and reviewed for site-specific procedural burden (imaging, laboratory, pharmacy requirements)
• Therapeutic area patient population assessed against site's historical screening-to-enrollment conversion data
• Site investigator confirmed to be actively practicing in the relevant indication, with verified current GCP training
• Site staffing capacity reviewed: do current open trials at the site create coordinator capacity constraints?
• Principal investigator availability assessed for the expected startup period; a 2024 Applied Clinical Trials analysis noted that the US lost roughly 55% of its active investigators between 2018 and 2023, and approximately 66% of current principal investigators participate in only one clinical trial ^[1]
• Site infrastructure verified: pharmacy capability, specimen handling per protocol, equipment availability, temperature monitoring for investigational product storage
• Regulatory history reviewed: any FDA Form 483 observations, warning letters, or prior audit findings that could complicate sponsor oversight

At the site level, initial feasibility response should include:

• Signed feasibility questionnaire with enrollment projections grounded in documented source patient populations, not optimistic estimates
• Confirmation that the identified PI holds current medical licensure and GCP certification
• Disclosure of competing trials with overlapping patient populations currently open at the site

Phase 2: Regulatory Package Preparation

Sponsor-Side Regulatory Documentation

Before any site-facing regulatory submission can proceed, the sponsor's regulatory package must be complete and internally reviewed. For US IND-covered studies, 21 CFR 312.23 specifies that the IND application must include the clinical protocol, investigator's brochure, chemistry, manufacturing, and controls information, and pharmacology and toxicology data ^[17]. Sponsors have 30 days after FDA receives the IND before the investigation can begin, unless the FDA notifies the sponsor earlier that the investigation may proceed ^[17].

Sponsor regulatory checklist (IND-covered studies, US):

• IND application submitted via FDA Form 1571 with all required components per 21 CFR 312.23 ^[17]
• Clinical protocol includes study objectives, endpoints, patient selection criteria, investigational procedures, statistical design, and PI responsibilities
• Investigator's Brochure (IB) current version distributed to all participating PIs
• FDA Form 1572 obtained from each investigator per 21 CFR 312.53, confirming the investigator's qualifications and agreement to conduct the study in accordance with the protocol ^[17]
• Financial disclosure information obtained from all clinical investigators per 21 CFR 54
• Investigational product labeling prepared per 21 CFR 312.6
• Any prior protocol amendments or IND safety report updates distributed to all sites before the Site Initiation Visit

Protocol document status check:

A common startup error is distributing a protocol version for regulatory submission that undergoes amendment before the SIV is scheduled. Any amendment resets downstream document preparation work and, in many cases, requires IRB re-review. Confirm protocol version stability before submission wherever possible.

Phase 3: IRB Submission and Approval

Regulatory Review Strategy

The choice between a central IRB (single IRB, or sIRB) and local institutional review has a documented effect on startup timelines. A cohort study by Goyal et al. (2021) published in JAMA Network Open, analyzing data from nine randomized cardiovascular clinical trials, found that sites using a central regulatory review process had a startup time of 199 days from protocol delivery to first enrollment compared to 287 days for sites using local IRB review ^[9]. A 2019 peer-reviewed evaluation of the SMART IRB reliance model, published in the journal Clinical Trials by Vardeny et al. and embedded within the INVESTED multisite influenza vaccine trial, found that mean time to IRB approval was substantially faster for sites that ceded local review to the single IRB compared to the one non-ceding comparator site ^[10]. The study was a pilot evaluation with a small sample and a single comparator, so its findings are directional rather than definitive; they are consistent with, and corroborated by, the larger Goyal et al. (2021) dataset.

FDA guidance recommends the use of a centralized IRB review process for multicenter trials, particularly noting that central review reduces administrative redundancy and promotes consistent study conduct across sites ^[11]. ICH E6(R3), adopted by EMA with effect from July 23, 2025, sets risk-proportionate oversight expectations and addresses quality management for technology-enabled trial conduct; sites and sponsors aligning to these expectations at the startup phase build the foundation for consistent oversight throughout the study ^[12].

IRB submission checklist:

• Final IRB-approved protocol version confirmed before submission; submit the version you intend to use for the trial
• Informed Consent Form (ICF) prepared per 21 CFR Part 50 and ICH E6(R3) Annex 1 requirements, including all elements of informed consent
• HIPAA authorization included where applicable
• Recruitment materials (advertisements, scripts, patient-facing letters) submitted for IRB review
• Investigator CVs, GCP training certificates, and medical licensure included in submission package
• Site-specific reliance agreements executed if using a central IRB at sites with local IRB policies requiring formal reliance documentation
• IRB submission tracking number recorded; follow-up protocol set for responding to any requests for modifications (RFMs) within the IRB's specified review cycle

While awaiting IRB approval:

Budget and contract negotiations can proceed in parallel with IRB review, but site activation cannot occur before IRB approval is received and documented. Under 21 CFR 56.103, no IRB-regulated clinical investigation may be conducted without prior IRB approval; no protocol-specific activities, including screening activities, may begin before that approval is in place.

Phase 4: Budget Negotiation and Contract Execution

The Critical Path Item Teams Most Often Underestimate

Contract execution is one of the most documented sources of clinical trial startup delay across the published literature. Lawrence et al. (2023), in the Journal of Clinical and Translational Science, reported average contract negotiation duration exceeding 100 days for multisite trials ^[6]. WCG's budget benchmarking data confirms that budget negotiations remain a primary bottleneck, with the average total contract timeline running approximately 63.8 days, and negotiations taking 5-10 hours of active effort per negotiator per study at minimum ^[5]. Budget negotiations averaged eight business days longer in 2023 than the prior year, driven partly by inflation-adjusted cost increases and staffing changes in legal departments at both sponsors and institutions ^[1].

Budget preparation checklist (sponsor side):

• Fair Market Value (FMV) analysis completed for all procedures and activities in the protocol
• Protocol-specific cost drivers identified: per-patient costs, overhead, patient reimbursements, screen failure allowance, pharmacy handling fees
• Budget template prepared that separates pass-through costs from professional fees
• Budget and contract review timeline communicated to sites at site selection, including sponsor-side turnaround expectations for redlines

Contract (CTA) execution checklist:

• Clinical Trial Agreement template uses sponsor's approved base language; sites notified that template drift will require escalation and extends timelines
• Indemnification, publication rights, data ownership, and termination provisions reviewed by sponsor legal before template distribution
• Sponsor-side routing procedure established with a single point of contact coordinating comments across clinical, legal, regulatory, and privacy teams; turnaround expectations communicated to sites upfront ^[13]
• IRB approval receipt confirmed before CTA execution if institutional policy requires
• Executed CTA filed in the Trial Master File (TMF) per ICH E6(R3) essential documents requirements ^[12]

Using standardized agreement templates where available significantly reduces negotiation cycles. The ACTA and FDP-CTSA frameworks both demonstrated savings of 48 to 57 days in the Lawrence et al. (2023) analysis ^[6], representing the largest single time savings available at the contract phase.

Phase 5: Site Readiness and Essential Documents

Building the Regulatory Binder Before the SIV

ICH E6(R3), finalized at Step 4 by the ICH Assembly on January 6, 2025, and adopted in final form by FDA in September 2025 (Docket FDA-2023-D-1955), sets out requirements for essential documents that must be in place before a clinical trial begins ^[12]. These documents demonstrate that the site has met the conditions necessary for the conduct of a trial and serve as the primary record reviewed during regulatory inspections.

Essential documents checklist (pre-trial, per ICH E6(R3) Annex 1 and FDA GCP expectations):

• Signed protocol and all amendments (current version)
• Investigator's Brochure (current edition with version date)
• Signed investigator agreement / Investigator Statement
• FDA Form 1572 (signed, dated, site-specific) for US IND-covered drug studies
• Financial Disclosure Form (FDA Form 3454 or 3455 as applicable)
• IRB approval letter and approved ICF (version-controlled)
• IRB approval for all recruitment materials
• CVs for PI, sub-investigators, and key study team members (current; many sponsors and institutions require CVs signed and dated within two years, though the specific recency requirement varies by institution and SOP)
• GCP training certificates for all study staff with delegated responsibilities (recency requirements vary by sponsor SOP and region; confirm sponsor-specific standards)
• Medical licensure documentation for the PI and any sub-investigators
• Delegation of Authority (DoA) log, identifying each team member's assigned duties and effective dates
• Site Personnel Signature Log
• Laboratory certification and normal ranges (current, from the accredited reference laboratory specified in the protocol)
• Investigational Product (IP) storage conditions confirmed in writing; temperature monitoring equipment calibration records on file
• Vendor readiness confirmed: EDC system access provisioned and tested, eCRF training complete, RTSM/IWRS access active if applicable

A note on document version control: Distributing any document before its IRB-approved or protocol-approved version is confirmed creates a chain of corrections that compounds document burden later. Filing sequence matters. The DoA log, for example, cannot accurately record training completion dates if training has not yet occurred. Build the binder in the correct chronological order.

Phase 6: Site Initiation Visit (SIV)

The Last Gate Before Enrollment Opens

The Site Initiation Visit is conducted after IRB approval and contract execution are confirmed but before the first participant is enrolled. Per established GCP practice, the SIV is a formal training session conducted by the sponsor's clinical research associate (CRA) or CRO monitor with the PI, study coordinator, pharmacy staff, and any other personnel with delegated study responsibilities ^[14]. Under ICH E6(R3), sponsors bear responsibility for providing adequate training to all individuals involved in study conduct, and the SIV serves as the primary vehicle for documenting that training has occurred ^[12].

SIV preparation checklist (sponsor or CRO):

• SIV agenda distributed to site at least five business days in advance, with a time estimate for each agenda item
• SIV presentation finalized against the most current approved protocol version
• Monitoring plan reviewed and key monitoring milestones communicated to site
• SAE reporting timelines and escalation pathways prepared for training
• Protocol deviation classification criteria reviewed; site briefed on what constitutes a reportable deviation
• EDC or eCRF training materials prepared; login credentials confirmed active

SIV checklist (on-site or virtual):

• Confirmation that all study team members listed on the DoA log are present or have received equivalent training
• Protocol walkthrough completed: study design, eligibility criteria, screening procedures, visit schedule, study-specific procedures
• Informed consent process reviewed: who may obtain consent, documentation requirements, re-consent triggers
• SAE/AE reporting procedures confirmed: timelines, required forms, sponsor contact information
• IP receipt, accountability, storage, administration, and return/destruction procedures reviewed with pharmacy staff
• Protocol deviation procedures confirmed: classification, escalation, documentation
• Emergency procedures and safety contact lists distributed
• Equipment availability verified against protocol requirements: all clinical assessment tools, laboratory centrifuges, specimen packaging, cold chain logistics
• EDC access confirmed for all personnel with data entry responsibilities; eCRF training documented
• RTSM/IWRS randomization procedures confirmed
• SIV attendance log completed and signed by all attendees
• SIV report issued by CRA within agreed timeframe; any open action items tracked with owner and resolution deadline

Enrollment cannot open until the SIV is complete, all action items are resolved, and the sponsor has issued written confirmation of site activation.

Phase 7: First Patient In (FPI) Readiness Verification

The 48-Hour Check Before Opening

The period immediately before the first participant is screened is where implementation gaps that survived earlier checklist review tend to surface. A structured pre-FPI review session, even a 30-minute call with the site coordinator, resolves these before they become protocol deviations.

Pre-FPI verification checklist:

• IP shipment received, temperature excursion log reviewed, IP accountability log initiated
• Pharmacy confirmed ready to dispense per protocol-specified dispensing instructions
• All DoA-listed staff have current GCP certification on file; any staff additions to the delegation log have completed protocol training before performing delegated duties
• Screening log initiated and version-controlled
• Emergency contact list posted per site SOPs; PI confirmed as primary medical contact for AE escalation
• IRB-approved ICF current version in use; site has process for distributing updated versions if an amendment triggers re-consent
• Site coordinator confirmed to have sponsor or CRO contact information for day-of-screening questions

Regulatory and Documentation Considerations

ICH E6(R3) and the Evolution of GCP Expectations

ICH E6(R3) introduced meaningful changes to how startup documentation and oversight are expected to function. The finalized guideline, adopted by the ICH Assembly on January 6, 2025, and subsequently published as final FDA guidance in September 2025 (Docket FDA-2023-D-1955) ^[12], reinforces several expectations directly relevant to the startup workflow:

First, E6(R3) formalizes a risk-proportionate approach to essential documents. The guideline emphasizes that sponsors and investigators should determine which documents are necessary based on the nature and complexity of the trial rather than defaulting to a single standardized list for all studies. This does not reduce the documentation burden for complex studies, but it shifts the framing toward purposeful documentation rather than rote compliance.

Second, E6(R3) sets expectations that technology systems used in the trial should be fit for purpose, validated, and have documented access controls that support data integrity. This includes EDC systems, eCRF platforms, RTSM tools, and CTMS systems. For studies subject to FDA oversight, 21 CFR Part 11 provides the regulatory framework for electronic records and electronic signatures; sponsors should confirm which systems require Part 11 compliance based on the nature of the data captured and the regulatory context of the trial. At the startup phase, access provisioning and any required system validation documentation should be in place before data entry begins.

Third, E6(R3) Annex 1 organizes essential documents by trial phase: before the trial begins, during the conduct of the trial, and after completion or termination. For sites, this structure clarifies what documents must be complete before activation and provides an audit trail reference point during inspections.

The EMA's implementation came into effect on July 23, 2025. Health Canada announced implementation effective April 1, 2026 ^[15]. Sites operating across multiple regulatory jurisdictions should confirm which version of GCP their ongoing trials are governed by and align their essential document structures accordingly.

AI and Automation in the Startup Workflow

Where Structured Technology Support Is Most Useful

Clinical trial startup involves the preparation, distribution, version-tracking, and execution-status monitoring of dozens of documents across multiple parties. The dominant failure modes are not scientific: they are administrative. WCG's 2025 Clinical Research Site Challenges Report identifies study startup as a consistent top challenge, with 31% of sites citing it as a primary issue in 2025 ^[4].

Automated document generation for startup-phase documents (protocol synopses, ICFs, IBs, delegation logs, site-specific addenda) reduces the manual preparation burden and enforces version consistency across sites. Cross-document consistency is particularly valuable at startup: an ICF that references an older protocol version, or a delegation log that lists a procedure not yet in the approved protocol, creates regulatory findings that are time-consuming to correct after the fact.

Electronic Trial Master File (eTMF) systems that enforce document receipt checklists against the ICH E6(R3) Annex 1 framework provide real-time visibility into which sites have completed which startup milestones, enabling sponsors to prioritize remediation efforts before the SIV rather than discovering gaps during post-activation monitoring visits.

Ken Getz's presentation of Tufts CSDD data at the 2024 SCOPE Summit reported that decentralized trial components had increased site burden by more than 25% in patient education and technology adoption, while North American site activation rates had fallen to approximately 62% ^[16]. Tools that match eligible patients against protocol criteria using EHR data before the SIV may reduce the elapsed time between site activation and first patient screened, providing coordinators with an evidence-based enrollment forecast before recruitment begins, rather than discovering screen failure rates only after activation.

Kitsa's KScreener uses FHIR-connected EHR workflows for patient pre-screening against study eligibility criteria. Running eligibility assessments against the site's existing patient population before the SIV gives coordinators a realistic enrollment forecast grounded in actual chart data rather than protocol-derived optimism, reducing the likelihood that a site's enrollment projections collapse in the first weeks post-activation. Kitsa describes KScribe as supporting regulatory document generation across the startup document portfolio, including protocols, IBs, and ICFs, with cross-document consistency checks designed to catch version drift before documents reach IRB submission.

Key Takeaways

• NCI recommends a 90-day site activation target, but actual times at NCI-designated cancer centers in 2024 ranged from 78 to 313 days, and WCG data places the median activation time for academic medical centers at 9.4 months for Phase I-III trials ^[1],[2].
• Activation time is directly associated with trial success: studies activating in a median of 140 days achieve meaningfully higher accrual rates than those taking 187 days ^[7].
• Budget negotiations and contract finalization are a major driver of study startup delay, consistently identified as a top challenge in WCG's annual site surveys (WCG-commissioned data); WCG benchmarking shows average total contract timelines of 63.8 days ^[4],[5].
• Use of standardized agreement templates (ACTA, FDP-CTSA) has been shown to reduce contract negotiation duration by 48-57 days ^[6].
• Central IRB review reduces startup time substantially: 199 versus 287 days in the Goyal et al. (2021) cardiovascular trial cohort; the Vardeny et al. (2019) SMART IRB pilot in the INVESTED influenza vaccine trial found substantially faster mean IRB approval times under the sIRB model ^[9],[10].
• ICH E6(R3), finalized in January 2025 and adopted by FDA in September 2025, reinforces risk-proportionate essential document frameworks and sets expectations for validated, access-controlled technology systems throughout the trial ^[12].
• The SIV is a regulatory and operational checkpoint, not a formality. All DoA-listed staff must be trained and documented before the first participant is approached.
• Hidden dependencies between startup phases (training cannot finalize until protocol is stable; DoA log cannot be complete until training is documented) are the primary reason checklists must be structured around execution risk, not chronology alone.

Frequently Asked Questions

References

1. [1]Smith, S. "Accelerating Clinical Trial Activation." Applied Clinical Trials Online, 2024. https://www.appliedclinicaltrialsonline.com/view/accelerating-clinical-trial-activation
2. [2]WCG / ACRP. "Overcoming Study Start-Up Delays: Best Practices for Research Sites." ACRP Blog, May 7, 2025. https://acrpnet.org/2025/05/07/overcoming-study-start-up-delays-best-practices-for-research-sites
3. [3]Smith, Zachary, Joseph DiMasi, and Kenneth Getz. "New Estimates on the Cost of a Delay Day in Drug Development." Therapeutic Innovation and Regulatory Science 58, 2024. See also: Tufts CSDD White Paper, "Quantifying the Value of a Day of Delay in Drug Development," July/August 2024. https://csdd.tufts.edu/sites/default/files/2025-02/Aug2024%20Day%20of%20Delay%20White%20Paper%20Final.pdf
4. [4]WCG. "2025 Clinical Research Site Challenges Report." Cited in: ACRP Blog, "Unveiling 2025's Biggest Site Challenges." ACRP, October 14, 2025. https://acrpnet.org/2025/10/14/unveiling-2025s-biggest-site-challenges-data-driven-insights-to-optimize-site-success
5. [5]WCG. "Clinical Trial Budgets: Current Trends and Questions Answered." WCG Clinical, originally published July 25, 2022. https://www.wcgclinical.com/insights/clinical-trial-budgets-current-trends-questions-answered-part-1/
6. [6]Lawrence, Colleen E., et al. "Quantitative Assessment of the Impact of Standard Agreement Templates on Multisite Clinical Trial Start Up Time." Journal of Clinical and Translational Science 7(1):e204, September 6, 2023. PMID: 37830004. https://pubmed.ncbi.nlm.nih.gov/37830004/
7. [7]Ratnayake, Isuru, et al. "Evaluating the impact of delayed study startup on accrual in cancer studies." Contemporary Clinical Trials Communications 48:101562, October 23, 2025.
8. [8]ICON plc. "From Bottlenecks to Breakthroughs: Human-Centred Solutions for Faster Study Starts." ICON whitepaper, 2025. https://www.iconplc.com/news-events/press-releases/icon-survey-reveals-increasing-clinical-trial-startup-delays
9. [9]Goyal, Akash, et al. "Assessment of North American Clinical Research Site Performance During the Start-up of Large Cardiovascular Clinical Trials." JAMA Network Open 4(7):e2117963, July 1, 2021. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2782213
10. [10]Vardeny, Orly, et al. "Transitioning to the NIH Single IRB Model: Piloting the Use of the SMART IRB." Clinical Trials 16(3):290-296, June 2019. PMID: 30866676. https://pubmed.ncbi.nlm.nih.gov/30866676/
11. [11]U.S. Food and Drug Administration. "Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for Industry." FDA, 2006 (updated). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/using-centralized-irb-review-process-multicenter-clinical-trials
12. [12]U.S. Food and Drug Administration. "E6(R3) Good Clinical Practice (GCP)." Final Guidance, FDA Docket FDA-2023-D-1955, September 2025. ICH Assembly Step 4 adoption: January 6, 2025. EMA effective date: July 23, 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp
13. [13]Association of Clinical Research Professionals. "Increase Efficiency in the Contract Negotiation Process During Study Start-up." ACRP Blog, December 20, 2023. https://acrpnet.org/2023/12/20/increase-efficiency-in-the-contract-negotiation-process-during-study-start-up
14. [14]Mount Sinai Research Roadmap. "Site Initiation Visit (SIV)." https://researchroadmap.mssm.edu/industry/site-initiation-visit/
15. [15]Health Canada. "Implementation of the ICH E6(R3) Guideline: Notice to Stakeholders." File No. 25-105890-674, October 17, 2025. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/implementation-ich-e6r3-guideline-notice.html
16. [16]Clinical Trial Vanguard. "Tufts CSDD: New Insights on the Clinical Trial Industry." Conference coverage of Ken Getz's presentation at the 2024 SCOPE Summit, March 21, 2024. https://www.clinicaltrialvanguard.com/conference-coverage/tufts-csdd-new-insights-on-the-clinical-trial-industry/
17. [17]U.S. Food and Drug Administration. 21 CFR Part 312: Investigational New Drug Application. Code of Federal Regulations, current version. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312