{"id":813,"date":"2015-06-02T20:00:10","date_gmt":"2015-06-02T18:00:10","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=813"},"modified":"2025-05-21T10:50:57","modified_gmt":"2025-05-21T08:50:57","slug":"what-do-investigators-expect-from-cra-and-site-study-coordinator","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/what-do-investigators-expect-from-cra-and-site-study-coordinator\/","title":{"rendered":"What do investigators expect from CRA and Site Study Coordinator?"},"content":{"rendered":"

Know how to communicate with investigating physicians<\/h1>\n

Are you Site\u00a0Study Coordinator or CRA monitor? Your role is to ensure\u00a0that the study is conducted in accordance with the protocol, Good Clinical Practice, the current Regulations and the standard operating procedures (SOP) (in French:proc\u00e9dures op\u00e9ratoires standardis\u00e9es (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\u00a0and investigator team. In this article you will find what the investigators really expect from you in a clinical trial.<\/p>\n

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1. Communication<\/h2>\n

The key to a well-run project is communication! Indeed, it is crucial that the SSC \/ CRA keeps the investigator regularly informed \u00a0about the study progress.<\/p>\n

If you’re Site study coordinator: the ideal is to be able to meet him face to face\u00a0(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…<\/p>\n

… Especially in case of serious adverse events (SAE)! If you discover one, inform the doctor\u00a0immediately! 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\u00a0send 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 \ud83d\ude42<\/p>\n

Communicate with\u00a0the 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!<\/p>\n

If you’re CRA monitor<\/span>: the ideal is to meet the investigator at each monitoring visit to talk about\u00a0the study. However, in his absence you can address\u00a0the Site Study Coordinator\u00a0who takes care of the study, the doctor will be informed in the monitoring visit tracking mail and also by phone. If \u00a0you could not meet the doctor several time when you come on-site, you can ask him if it is possible to schedule\u00a0a telephone meeting.<\/p>\n

2. Time-saving<\/h2>\n

a. Concerning administrative documents<\/h3>\n

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\u00a0documents.<\/p>\n

If you’re SSC<\/u>: Print documents to be signed by\u00a0the investigator. Of course, if you have several documents that need the doctor’s signature, gather\u00a0everything to make it easier. Along\u00a0the 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.<\/p>\n

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\u00a0the right place. It\u00a0is 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.<\/p>\n

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\u00a0the doctor and his team (nurses, laboratory, pharmacy).<\/p>\n

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.<\/p>\n

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.<\/p>\n

If you’re CRA monitor:<\/u> if a document has to be created (note in the\u00a0file, 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\u00a0for the doctor validation and signature. This is also your role to check\u00a0the consent compliance and eligibility criteria.<\/p>\n

b. Regarding the patients monitoring (valid only for the hospital CRA)<\/h3>\n

In a clinical trial, the Site Study Coordinator\u00a0has a central role in the selection, inclusion and the patient follow-up. Indeed, he\u00a0can help the doctor:<\/p>\n