What do investigators expect from CRA and Site Study Coordinator?

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Know how to communicate with investigating physicians

Are you Site Study Coordinator or CRA monitor? Your role is to ensure that the study is conducted in accordance with the protocol, Good Clinical Practice, the current Regulations and the standard operating procedures (SOP) (in French:procédures opératoires standardisées (POS)) of the promoter. You know a clinical trial success management depends on several things such as good monitoring tools, good organization, etc. This also requires good communication with the doctor and investigator team. In this article you will find what the investigators really expect from you in a clinical trial.

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1. Communication

The key to a well-run project is communication! Indeed, it is crucial that the SSC / CRA keeps the investigator regularly informed  about the study progress.

If you’re Site study coordinator: the ideal is to be able to meet him face to face (you make an appointment with him for a short working session), but e-mails or telephone calls may be sufficient in the short term (avoid post-it, they can get lost easily!). This will allow him to know what is happening in real time and intervene if needed…

… Especially in case of serious adverse events (SAE)! If you discover one, inform the doctor immediately! He must complete and send the SAE Declaration Form to the pharmacovigilance within 24 hours following the situation. To save time and if you know you will not see your investigator within 24 hours, you can prefill the document with the information at your disposal, then send it to pharmacovigilance until the doctor completes, corrects and signs it. Once the document dated and signed by the doctor, do not forget to return it to the pharmacovigilance within the deadline 🙂

Communicate with the investigating doctor, is good. Also, communicate with team members, is better! In fact, if the information you need for the CRF is missing from the medical file, you can get information from nurses, biologists, laboratory analysts or pharmacists, they might be able to inform you!

If you’re CRA monitor: the ideal is to meet the investigator at each monitoring visit to talk about the study. However, in his absence you can address the Site Study Coordinator who takes care of the study, the doctor will be informed in the monitoring visit tracking mail and also by phone. If  you could not meet the doctor several time when you come on-site, you can ask him if it is possible to schedule a telephone meeting.

2. Time-saving

a. Concerning administrative documents

You know that doctors are very busy and have very little time, between consultations, meetings…. So to lighten their work, you can help by anticipating and preparing some documents.

If you’re SSC: Print documents to be signed by the investigator. Of course, if you have several documents that need the doctor’s signature, gather everything to make it easier. Along the documents collection, and according to the promoter procedures, send the originals to the CRA monitor (initially digital version, then in a second time by mail) if it is material.

You can highlight the information to be completed by the doctor with a post-it stuck on the edge of the sheet so that the investigator signs in the right place. It is also your role to regularly update the investigator workbook, this will save you time, especially in case of an imminent monitoring visit! The documents can then be found easier when the CRA will ask you.

At the same time, update regularly case report forms (resolution of requests for correction with the help of the doctor …). If you realize that a study process is not respected or that information is missing in the patient record, inform the doctor and his team (nurses, laboratory, pharmacy).

You can suggest a check-list creation by visit to ensure that all information required by the protocol are collected. You can also create a document that the investigator will complete if necessary, and will sign to follow up on concomitant medications or adverse events for example.

And do not forget, it is important to ensure that the consent is consistent (filled-in information, dates and signatures of the investigator and patient). If there is a non-compliance, review with the investigator to set up an action plan.

If you’re CRA monitor: if a document has to be created (note in the file, for example …), to be completed or signed by the investigator, prepare it: pre-fill it and send it to the monitoring center with the letter monitoring, or by email to hospital study coordinator for the doctor validation and signature. This is also your role to check the consent compliance and eligibility criteria.

b. Regarding the patients monitoring (valid only for the hospital CRA)

In a clinical trial, the Site Study Coordinator has a central role in the selection, inclusion and the patient follow-up. Indeed, he can help the doctor:

  • during the patients pre-screening (subjected to investigator approval): In this case, you will select patients meeting the hospital or service database inclusion criteria and propose them to the investigator. You can attend medical meetings where patients “cases” are discussed and assist in the identification of patients for your studies.
  • in the criteria eligibility checking
  • in the planning and management of patient visits. For example, during the patient’s inclusion visit, make sure that all the examinations required by the Protocol are achieved. To do this, check that meetings with various parties (radiologist…) have been arranged. Remind the patient the time and place of his appointment before his arrival onsite for the protocol visit. This will prevent protocol deviations.
  • during consent collecting assistance. Mind that it is the investigator who has to give information to the patient, to sign and make the patient sign the informed consent form. However, you can help by preparing briefing notes and informed consent forms. It is your duty to ensure patients understanding, complete the information if needed and answer to any patients’ questions on the protocol. Of course, if the patient asks medical questions, it is not in your skills to answer him, doctors only are able to answer.
  • Patient follow-up: call patients for collecting information or for reminding documents (patient diary, self-questionnaires), answer questions from patients, organize every visit….

Besides, a good patients monitoring will allow you to avoid drop-outs, early departure, and missing data, and therefore, you will have a better quality of the study results.

3. Availability and logistics management

The availability of the Site Study Coordinator / CRA is also an expectation of the doctor; especially if he needs information. Whether you’re a hospital CRA or CRA monitor, efficient monitoring tools will allow you to provide quickly and efficiently the information requested by the doctor (dates of inclusion, randomization, follow-up visits, phone calls, etc.). So do not underestimate monitoring tools!

If you’re Site Study Coordinator: Regarding logistics, Study Coordinator performs the samples management (preparation and sending to the centralized laboratory,…), ensures that the pharmacy dispenses the patient treatment and the patient returns non-used experimental drug to the pharmacy. If necessary, he can prepare the patient transport, the documents for the patient expenses reimbursement, …

It is also Site Study Coordinator’s duty to welcome CRA monitor during monitoring visits (provision of medical records, investigator workbook, meeting room booking, etc.).

If you’re CRA monitor: This is also your role to make sure that both treatments have been delivered and / or recovered by accounting the treatments and informing the investigator in case of inconsistency, deviation, violation of the protocol.

You have understood, as Study Coordinator, your role is to lighten the investigator workload by being organized and communicating regularly with him about the study. Your presence is essential for the study running success, the obtention of the best results, but also for building a relationship of trust with the doctor, the investigator team and the CRA monitor.

However, remember that throughout the study, the Study Coordinator remains under the investigator hierarchy. Therefore, before any action, you must have his consent 🙂

As CRA monitor, it is your duty to regularly communicate with the hospital study coordinator and the doctor about the study, by mail, telephone or during visits on the site in order to contribute in the study smooth progress. Remind them if necessary, you are there for that 🙂

I hope this article helped you to know more about what the investigators expects from a Study Coordinator and an ARC. If you need some tips to communicate effectively, an article about this subject has been written in the blog. Ask us your questions in the comments!

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Recherches utilisés pour trouver cet article :la visite de monitoring le role du technicien
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