Steps for a Successful Study Startup
Study startup is a critical stage in a clinical trial to get the study up and running. Efficient study startup lays an important foundation for the trial’s overall success.
Study startup is commonly defined as the activities occurring after most of the protocol is developed and before the first patient is enrolled in the study at each research site. Study startup is a complicated process and prone to delays due to the many stakeholders and systems involved.
Unlike research milestones dictated by the protocol, study startup timelines can vary, allowing research teams to save significant time and resources when executed efficiently.
There are three broad milestones within the study startup process, each of which includes important steps sponsors, contract research organizations (CROs), and sites must take to successfully start up their clinical trial.
Feasibility, Budgeting, and Contracting
Build a Budget
Sponsors must outline a budget to determine where to allocate resources to conduct a clinical trial. Some factors to consider when developing a budget include staffing, outsourcing, technology investments, shipping, site reimbursements, and more.
Identify and Contact Sites
Sponsor and CRO teams look for sites with the appropriate tools and infrastructure, patient population, and experienced investigators to help them conduct their trial. Sponsor and CRO teams should consolidate and evaluate various site lists or leverage feasibility tools and other data to locate the appropriate site contact to send the site feasibility questionnaire (SFQ).
Execute the Confidential Disclosure Agreement
Once a site learns about the proposed clinical trial after reviewing the SFQ from the sponsor, the site must sign a confidential disclosure agreement (CDA) to guarantee no confidential information is shared before or after the site evaluating their trial participation.
Conduct Feasibility
Feasibility is the process of evaluating a site’s ability to execute their part in a clinical trial. This is often surveyed and measured with an SFQ deployed by sponsors to sites. A site must examine their resources and patient databases to ensure they are prepared to conduct the trial. Upon receipt of a completed SFQ, a sponsor or CRO study team will select the group of sites to activate for the trial. Once selected, a sponsor may conduct a site-selection visit to confirm what the site reported in the feasibility questionnaire.
Initiate and Negotiate the Clinical Trial Agreement (CTA)
The CTA is signed by the sponsor, the site, and each site’s principal investigator (PI) which dictates each party’s responsibilities and obligations for the trial. Agreement negotiation can sometimes last weeks or months due to funding implications and publication rights.
Dig Deeper:
Ethics Committee Reviews
Ethics committees must review and approve the protocol and other documents before a site is ready to enroll participants. In the U.S., both sponsors and independent researchers, commonly known as investigators, working on behalf of sponsors are subject to institutional review board (IRB) oversight.
Sponsor Ethics Review Submission
Sponsors will submit their protocol and information about the investigational product (IP). They’ll also submit the template consent documents, and any other materials patients will receive to explain the trial to them. Once these elements are approved, the IRB will turn to review the individuals (aka the investigators) conducting the research.
Investigator/Research Site Ethics Review Submission
Each research site submits a short application to the IRB to verify the investigator has the appropriate credentials, facilities, and staff to safely conduct the trial. The submission should also include:
- The investigator’s curriculum vitae (CV) and medical license
- Study information, including:
- The clinic
- Staff involved in the research
- Expected number of participants enrolling in the trial
- Prior experience with conducting trials in the disease modality or similar disease conditions
Each research site submits a short application to the IRB to verify the investigator has the appropriate credentials, facilities, and staff to safely conduct the trial.
The IRB’s objective is to confirm each investigator is qualified to conduct the trial per the already-approved protocol.
Partnering with a central IRB in the U.S. can reduce review turnaround times while ensuring thorough and expert regulatory oversight. Additionally, automated routing of documents between your central IRB and your electronic trial master file (eTMF) offers the potential for additional time, labor, and quality improvement.
Site Activation
Collect Regulatory Documents and Critical Submissions
The collection of regulatory documents in a clinical trial act as a record of trial activity. As the International Council for Harmonization (ICH) dictates, every trial has a set of documents to collect and store long-term in two consolidated areas: the eTMF for the sponsor and the electronic investigator site file (eISF) for the site.
Most documents required for study submission are collected study startup. Examples include training certificates, ethics board submissions, investigator CVs, and more. You can accelerate study startup by leveraging technology designed to streamline the exchange of documents and keep track of what documents are still needed.
Conduct Study Training
Training prepares sites to conduct the trial and ensures the protocol is executed compliantly. Some types of training are required for every study like good clinical practice (GCP). Other training is related specifically to each protocol. It’s important to reduce the need for redundant training at the site level to keep study startup moving efficiently.
Once sites have completed their training, the training completion certificates should be shared with sponsors for long-term storage.
Discuss Patient Recruitment Planning
In their feasibility surveys and calls to action, sites and sponsors have identified the target number of patients to enroll at each site conducting the study. To increase the likelihood of achieving study enrollment, sponsors and sites must work together to outline the tactics they’ll use to recruit patients to their study. Tactics could include advertisements, contracting with referral companies, or hosting an educational session.
Conduct Site Initiation Visits (SIVs)
Once a site has conducted their study training, the study monitor acting on behalf of a sponsor conducts an on-site SIV to validate the site is fully prepared to begin enrolling patients. This is also an opportunity for sites to clarify any outstanding questions before engaging patients. The SIV is a required event by the FDA with requirements on specific activities and who must be present.
Initiate Patient Recruitment Activities
After the SIV, each site will work to recruit the necessary patients to the trial. To enroll a patient into the trial, site staff must manage patient referrals, prescreen patients to determine eligibility, and consent the patient. Study startup ends once each site has enrolled their first patient on that study, known as first patient in (FPI).
Accelerate Study Startup with Advarra
Our comprehensive study startup solutions empower clinical research teams with efficient workflows, expert teams and services, and integrated technology to help you accelerate critical milestones and improve operational outcomes.
achieved during initiation of large phase III vaccine trial
automating flow of Advarra IRB documents into sponsor’s eTMF