{"id":13634,"date":"2016-09-28T17:08:00","date_gmt":"2016-09-28T15:08:00","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=13634"},"modified":"2025-05-21T10:48:12","modified_gmt":"2025-05-21T08:48:12","slug":"clinical-site-coordinator-how-to-avoid-protocol-deviations-in-my-center","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/clinical-site-coordinator-how-to-avoid-protocol-deviations-in-my-center\/","title":{"rendered":"Clinical site coordinator, how to avoid protocol deviations in my center?"},"content":{"rendered":"

As a clinical site coordinator, you are a major player in the conduct of a clinical trial in your center. Despite your work, sometimes the protocol is not respected, it is a deviation from the protocol. These deviations should be avoided as much as this results in a drop in the quality of the study data and this gives a poor image of your center.<\/p>\n\n\n

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\"D\u00e9viation<\/figure>\n<\/div>\n\n\n

TEC DEVIATION PROTOCOLAIRE<\/strong><\/p>\n\n\n\n

If your center makes too many deviations, the promoter may decide not to involve your center in a future study. And that says less studies, says less money for your service, which can lead to the long-term suppression of clinical site coordinator positions. It is therefore to your advantage to help the investigator to provide quality research. Of course, you are not alone and other players intervene in deviations from the protocol (nurses, investigators, pharmacies and even patients), here are some keys to organize your work and facilitate the work for the players as it is not their initial function.<\/p>\n\n\n\n

You are dismayed to see the follow-up letters of monitoring visit contain deviations and no longer know what actions to put in place for the protocol to be respected? Here are some tips to avoid deviations from the protocol in the future and become the preferred center of CRAs<\/p>\n\n\n\n

Anticipating problems<\/strong><\/h2>\n\n\n\n

A new study will begin at your center and the CRA of the promoter or the CRO will go to your department to present the study. During the implementation, take notes and ask all the questions necessary for a good understanding of the study. Some protocols can be complex, if you’re not sure you understand a point, ask the CRA. There are no bad questions!<\/p>\n\n\n\n

Note<\/p>\n\n\n\n

Assist people whose research is not the primary role<\/strong><\/h2>\n\n\n\n

Depending on your level of involvement in your center, the investigator will ask you to help him or not to screen his patients. If you have the opportunity, check the criteria for inclusion and non-inclusion of patients that the investigator wants to include in the study before they come. The error is human, this will allow you to ensure that all the criteria are respected and thus avoid the inclusions wrongly!<\/p>\n\n\n\n

Secondly, think about facilitating the lives of people whose primary role is not research and who have no reason to respect the protocol. Take the protocol and the CRF and check all the information you need visit per visit. The purpose here is to identify procedures that are not part of current practice and data that are not usually collected in the service. You can, for example, prepare a sheet that the nurses will complete to ensure that they collect all the data at each visit, such as weight or respiratory rate.<\/p>\n\n\n\n

If you are preparing a document to collect the data directly, do not forget to provide a place for the person who collected the data to be able to indicate his\/her name, to date and sign, it will be a source document. Indeed, remember the ALCOA!<\/p>\n\n\n\n

You may also prepare procedures for nurses, if not provided by the promoter, especially if the study involves biological samples that should be sent to a centralized laboratory (equipment to be used, etc.).<\/p>\n\n\n\n

Finally, if the samples are analyzed locally, you can plan with the investigator ready prescriptions including all the analysis provided by the protocol per visit. Indeed, certain elements are not analyzed in everyday practice.<\/p>\n\n\n\n

Similarly, if the study involves treatment and the promoter has not anticipated it, discuss it with the investigator and the pharmacy, it may be worthwhile to prepare a prescription model.<\/p>\n\n\n\n

\u00a0Communicating with the care team<\/strong><\/h2>\n\n\n\n

As mentioned above, you are not the only one involved in the study and it happens that other actors whose clinical research is not the first role to be involved in the study: nurses, pharmacists, radiologists\u2026 Go to see them directly, present your study and the importance of collecting this data. It’s up to you to use your persuasive power to ask them to do an extra work. You can apply the communication techniques we had given to CRAs. Provide them with a procedural idea that can be implemented and listen, they may be able to suggest a way of doing things that you have not thought of and that will be more adapted to their daily practice.<\/p>\n\n\n\n

Ensure that all people who are likely to see the patients in the study are all adequately trained in the specific procedures of the study and make sure to answer their questions. Think about changes in staff, identify several key players and their back-ups. Also involves potential superiors, such as healthcare executives, to help you put the study in place.<\/p>\n\n\n\n

Finally, verify that roles are clearly defined. You can offer to lighten the work of some actors by implementing procedures yourself. The pharmacy refuses to count the treatments? What’s stopping you from doing it, you? This will allow you to directly identify a non-compliant patient and talk to him.<\/p>\n\n\n\n

You may be able to accompany the first patients from one department to another so that the actors are reminded that they are special patients and that the procedures of the study should be applied.<\/p>\n\n\n\n

Preparing for the patient arrival<\/strong><\/h3>\n\n\n\n

That’s it, everyone was trained, the first patient identified and the visit was booked.<\/p>\n\n\n\n

Before the start of the study, prepare checklists of action to implement for a visit, during the visit and after the visit. So, at time T, you will only have to follow the checklist and check what you have already done. This will allow you to easily identify possible omissions.<\/p>\n\n\n\n

A few days before the arrival of the patient, prepare your visit using the already prepared checklist, prepare the documents you will need during the visit and that you will have already listed:<\/p>\n\n\n\n