Eight Essential Steps for Successful Study Start-Up
Hear from a top Spark team member – Rebecca Mickalites, Clinical Project Manager (CPM) Consultant on the eight steps for successful study start-up.
We all know the challenges in clinical research can range from patient recruitment and retention to regulatory compliance to data integrity and management, among many others. Study start-up can have its own challenges. Getting a study started efficiently and effectively in the beginning can launch a catapult of decisions and momentum that save money and time. Thus, it’s important to be organized, know what to set up first and start communications early and effectively. The following eight steps can ensure timelines are met appropriately while also saving money.
Our eight steps begin when you have a protocol and have selected investigative sites to participate. What now? It’s time for … Study Start-Up!
- Build a Dedicated Team
Ensure the team is dedicated and can establish strong, collaborative relationships with the investigative site staff. A positive working relationship is crucial, as a site’s experience during start-up can have a lasting impact on their enthusiasm and participation throughout the study. Thus, be sure to start out on the right foot!
- Finalize Contract and Budget Early
Who will finalize the contract and budget for sites? The contract and budget are ALWAYS rate-limiting factors in study start-up, therefore it’s essential to start this process immediately. Identify the appropriate team members to begin reviewing contract language and budget negotiations as soon as possible. A call between the sponsor (or designee) and the site is encouraged and can set the team up for success.
- Understand Each Site’s IRB Submission Requirements
Investigative sites may have different requirements to prepare for submission to their IRB. Early on, discuss these requirements with each site to aid in developing a realistic timeline for IRB submission. Be mindful of IRB meeting dates, as IRBs may require the submission of documents several weeks prior to the meeting date. Avoiding these delays at the start of the trial is crucial.
- Provide a Clear and Comprehensive ICF Template
Provide sites with a comprehensive informed consent form (ICF) template to review early. Clearly outline what can and cannot be changed in the ICF. If there are any questions or issues regarding the form, schedule a call between the site and sponsor/designee. This collaborative approach helps ensure that everyone is aligned and can expedite the process.
- Organize and Streamline Required Documents
To make the document submission process as efficient as possible, compile all required documents into a single zip file. Include a cover letter which outlines the required documents and provides clear guidelines for completing each. This will save time and reduce confusion for both the sponsor and the site.
- Maintain Open Communication Throughout
Consistent and transparent communication is essential for keeping timelines on track. Regularly check in with sites to ensure that the study start-up process is progressing smoothly. If delays occur, be transparent and disclose any issues in real time. This builds trust and helps manage expectations.
- Schedule the Site Initiation Visit (SIV)
Once the contract is fully executed, there is an approved budget, the IRB approval is complete, and all necessary regulatory documents are collected and in place, it’s time to schedule the SIV. Work closely with the site staff to find a time that works for everyone involved. Flexibility is key! The SIV should accommodate all site staff, so plan appropriately.
- Activate the Site After Successful SIV
After a smooth SIV, it’s time to activate the site! While hiccups are inevitable during study start-up, how this is handled speaks volumes to the investigative sites. By fostering a positive relationship and maintaining open communication from start to finish, trust and collaboration naturally follow, ultimately making your study a success. True effort, of course, will be reflected in the enrollment numbers. Patient recruitment will be thankful!
Find success study start-up through Spark Clinical Research
Spark Clinical Research specializes in connecting you with the right professionals to ensure the success of your clinical trial. Our extensive network includes experts in study start-up and all of clinical operations, biometrics, medical writing, regulatory affairs, and more. With a wealth of experience, we collaborate closely with you to craft tailored, flexible solutions that ignite success for your clinical trials from start to finish. Learn more about our services and how we can help make your study start-up a success. Contact us today!