Your study is at the beginning of Study Initiation! You’ve just completed the Project Kick-Off meeting between the Sponsor and CRO teams to align on study expectations, timelines and priorities for Study Initiation. You discussed core documents, preferred vendors, site feasibility and even decided to organize an Investigator Meeting. As you walk away with your actions as a Clinical Trial Manager, your next goal is to provide a few dates for consideration for the First Site Activated milestone.
Planning for the First Site Activated milestone will ensure it is timely and successful. It is best to wait until the protocol is finalized before planning otherwise the milestone may fluctuate. Keep reading for more tips for CTMs planning for First Site Activated.
Pro Tip:
Some Sponsors consider First Site Initiated and First Site Activated to be the same, but others say these events are different, so you will want to clarify this to be sure you are aligned.
What is First Site Activated in a clinical trial?
First Site Activated occurs when the first site meets the criteria for site activation based on the Site Activation Checklist.
When is a site ready for Site Activation?
When the Site Activation Checklist is complete, a site is ready for site activation. The Clinical Trial Manager gives the site the “Greenlight” to begin screening. This notification is typically emailed to the site and filed in the Trial Master File (TMF).
Items to include on the Site Activation Checklist
CTMs or a designee must complete the Site Activation Checklist before a site can begin screening. Here are a few items that must be confirmed are in place:
- Fully executed site contract
- Site-level IRB/EC approval
- All site regulatory documents received
- Investigational Product (IP) on site
- Study supplies on site (including lab kits, patient diaries, etc.)
- Investigator Site File on site
- Site Initiation Visit completed
*Pro Tip*
If getting sites activated as quickly as possible is a priority, some items on the Site Activation Checklist can be completed out of order for instance, IP may be shipped to a site after they are activated and start screening patients. If you want to make a change to the Site Activation Checklist, please get permission from the Sponsor to document this decision.
The tasks on a Site Activation Checklist are discussed in detail in the ClinEssentials CTM Training Course.
What can a CTM do to ensure the First Site Activated milestone is successful?
Clinical Trial Managers can make sure the First Site Activated milestone is successful by producing an organized and well-thought plan.
Additionally, it is helpful when CTMs have mitigation strategies if their plan or Site Activation Checklist needs to be revised. The ability to think outside the box is beneficial for keeping timelines on track.
Here are five tips for CTMs when planning for the First Site Activated milestone:
- Make sure the protocol is finalized.
A protocol that will not be amended soon will lead to a streamlined start for First Site Activated. Protocol amendments during Study Initiation cause re-work as plans, vendors, etc., build study specs for one version and are then required to make changes in order to comply with the amendment. This will also result in additional fees for extra time spent.
You will save time, money and be better able to stay on schedule with study timelines when you have the finalized protocol. If there is a chance your protocol will change, discuss the potential for a delay with the First Site Activated milestone early with your Sponsor.
- Review the list of Central IRBs vs. Local IRBs sites on your study.
All sites need IRB/EC approval prior to activation. There are two types of Institutional Review Boards (IRBs) a site may have – Central IRB or Local IRB. As a CTM, you need to be aware of the timelines for approval across both Central and Local IRBs to help you plan.
What is a Local IRB?
Local IRBs are associated with independent research institutions such as universities/ academic centers and provide approval for one Investigator to participate in the study. The local IRB committees from these academic institutions evaluate potential studies based on the institution’s policies and procedures keeping in mind the potential impact of the trial on the rights and welfare of patients.
The local IRB review process tends to take anywhere from 4 – 16 weeks depending on the amount of protocols in the queue, limited meeting schedules (bi-monthly), sub-committee reviews and other requirements such as review of the site contract/budget before IRB approval can be granted.
If your study has too many local IRBs, overall activation timelines can be delayed.
What is a Central IRB?
A Central IRB is a single IRB that reviews research proposals for multiple Investigators. They monitor research for all sites participating in a clinical trial who are able to use a Central IRB.
Central IRBs generally have faster turnaround times (48 hours – 2 weeks) due to a more streamlined review process. The overarching study protocol is reviewed first and then, once the study is approved, individual Investigators are reviewed and added to the study as a participating site quickly.
As a CTM, it is helpful to know the breakdown of how many of your sites are Central versus Local IRBs early during the Study Initiation phase of the study so you can factor in the different approval timelines.
- Ensure you have CRA resources in place.
CTMs want to work with Project Resourcing during Study Initiation so they know when a Clinical Research Associate (CRA) should be assigned. Ideally, a CRA will join the research team ~ 2 weeks before the first Site Initiation Visit (SIV) to allow for training and on-boarding.
Remember, if a study does not have a CRA, the CTM may be responsible for carrying out the CRA’s tasks until the role is filled or timelines may have to be pushed until a resource is identified. This makes Tip #3 even more important!
- Work with vendors for supplies, equipment, and manuals.
A site can’t start screening without all of the supplies, equipment, and manuals that are indicated in the protocol. It is the CTM’s job to work with the vendors to ensure all necessary items are created, shipped and received. CTMs need to have regular meetings with all of their vendors to ensure activities remain on target. Not having lab kits or IP can prevent a site from being activated!
- Work with Data Management (DM) to build the Electronic Data Capture (EDC) database.
CTMs meet with Data Management (DM) regularly to make sure the programming and design of the Electronic Data Capture (EDC) is moving along in accordance with the study timeline. EDC is a database used to collect, clean and store clinical trial participant data. It is ideal to have the EDC ready prior to the First Site Activated milestone, however in a pinch, the EDC can go live shortly after the milestone is achieved.
As you can see, First Site Activated is a significant milestone that requires detailed planning, cross-functional collaboration, and effective communication. Following the five tips above will help you move in the right direction to meet the First Site Activated milestone.
And there are more details and more tips where these came from!
How to learn more about Clinical Trial Management
First Site Activated is just one of the many crucial responsibilities of Clinical Trial Managers that are discussed in the ClinEssentials CTM Training Course.
This article includes five suggestions that will enable you to start on the right track when planning for First Site Activated. The CTM course takes these suggestions to another level with comprehensive information about what a CTM does from Start-Up to Close-Out. Pro Tips, templates and bonuses are sprinkled throughout the course, along with activities based on real CTM examples.
The All Access + LIVE Course is for aspiring and new Clinical Trial Managers who will benefit from self-paced learning modules along with weekly live training sessions and direct access to the expert instructor. Register now for a spot in an upcoming course.
Experienced CTMs may prefer the Self-Paced Course, in which you can watch videos and complete workbook activities as your schedule allows. Buy now and receive immediate access to the course content.
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