January 12 2022
Written by Melissa Yurch, Research Coordinator III at the Cleveland Clinic
Starting up a new study can be time consuming and often met with roadblocks from the IRB, legal, etc., which are all OUT of your control. These roadblocks leave you waiting and with time on your hands. Use that time to get organized and efficient.
A way to keep moving with startup is to work on the items that ARE in your control. Being detailed about the enrollment process, lab kit builds and collection, and data collection, can help overcome obstacles prior to opening the study and alleviate questions of responsibilities once it is opened.
Think about who will be doing each task as the protocol states. Communicate with those on your team. Contact those that will be involved in the study outside of your department. Find out their processes and what you can provide that will help them complete the tasks you need them to. Checklist for each task are great tools and easy to follow. Especially for those outside your department.
I like to envision enrolling a patient and what steps are necessary and then move on from there. Then, I create a process sheet. Here are some examples I include in my process sheet:
Enrollment Process
- Who is able to consent the patient?
- Create an easy way to document the patient was consented in the medical record.
- Create a consenting process checklist that ensures you have informed the patient about all the required elements in the consent form.
- What systems does the patient need to be entered into to be on the study
- Who should be notified when a patient signs the consent?
- Who should get deidentified notification with Study ID# only?
Research Team Process
This is where you spell out who is responsible for what from the research coordinator, nurse, and labs or tissue procurement.
- Who confirms that the patient is consented and that it is documented in the medical record?
- Who assigns the Study ID# and distributes it to whom?
- With or without identifiers?
- Update the other systems that need completing when a patient is enrolled and Study ID# is assigned.
- Who puts the lab kit together if one is needed?
- When does that lab kit need to be at the lab and where is the lab?
- Who will be responsible for taking it to the lab and/or picking it up from the lab?
- Who is your contact person?
- Who will process, store, and ship the samples?
- What lab are the samples to be shipped to?
- Contact person in Pathology, the process by which to request and obtain tissue samples
- Who ships the tissue samples and to which lab are they shipped to?
Kit Preparation, Surveys, etc.
Prepare as much in advance as you can by creating templates to be used for labels you may need. I like to have all the labels needed for a kit on one sheet. I have it set up for labels to print. This way, I update the information on the label and then the coordinator can print it as time permits.
Patient surveys and patient diaries can be prepared the same way but not until they are IRB approved whether you are using CIRB or local IRB. For these, I try to stay one visit ahead, just in case something might change. Always make sure that you are using the current stamped version to avoid deviations.
Data Collection
Determine in advance who is going to be responsible for data entry and make sure they have access to all the systems they need. If you are using a system such as Medidata Rave, build the project while you are waiting for approval. You can then move it to production once you have the IRB approval.
I like to have a checklist available to view with bullet points of what systems need updating when a patient is enrolled. It’s easy to miss one otherwise.
If you spell everything out, there is less room for error. There are no assumptions made of who knows how to do what and who is responsible for what.
You can always update your process sheet after the first two patients. There will always be room for improvement.
Once the study is approved and active, all tasks will have been assigned and team members will be aware of their tasks and ready to rock and roll with the first patient.