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.

TEC DEVIATION PROTOCOLAIRE

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.

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

Anticipating problems

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!

Note

Assist people whose research is not the primary role

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!

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.

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!

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.).

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.

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.

 Communicating with the care team

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… 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.

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.

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.

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.

Preparing for the patient arrival

That’s it, everyone was trained, the first patient identified and the visit was booked.

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.

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:

• The latest version of the consent form and the information note to the patient if this is the patient’s first visit or if the study has been amended,
• Documents to be given to the patient (follow-up diary, self-questionnaires to be completed…)
• All worksheets for each of the actors involved in the study,
• Possible prescription models,
• Biology kits.

You can even plan an « inclusion pack » with all the necessary documents in a package, this way, no more stress, if you have to include an emergency patient, everything is ready and you will not forget anything.

If your center is equipped with clinical research management software, enter all the data from the study and configure it so that it regularly reminds you of the actions that you have to implement in the context of the study.

Do not forget to call the patient a few days before his arrival to make sure he will come. This is the time to remind him to bring back the empty treatments under study or follow-up diaries, if necessary.

 Follow-up of the patient’s arrival

During the patient visit and prior to his departure, check your checklist and worksheet to ensure that everything is in accordance with the study protocol. You can then try to make up for possible omissions before the patient leaves the center.

If the patient has to fill out questionnaires or perform actions at home, remind him before leaving. Maybe you can suggest to phone him, at least the first time, to remind him. Discuss with the patient and, again, listen and suggest solutions to help.

Check his contact information so you can reach him easily and book his next arrival before he leaves. Do not forget to indicate the arrival of the patient in your diary and to envisage automatic recalls to the times planned by the protocol.

Finally, think about questioning regularly the investigator to check that everything is going well and that there is no information that has escaped you: difficulties that the investigator may encounter or even occurrence of a serious adverse event. Check the patient’s medical record, including letters from other physicians to verify that there have been no serious adverse events to report. As far as serious adverse events are concerned, we discussed this in an article.

 Put in place corrective and preventive or curative actions

Despite all the actions implemented, a deviation from the protocol took place. Sometimes the deviation can be « corrected » and the information can still be retrieved. Put in place a curative action to solve this problem. This can take several forms: ask the investigator to retrieve the data on a next visit, arrange for an additional test at the patient’s next visit, if it is very urgent, contact the patient by telephone, etc.

The deviation from the protocol has occurred, but it will not have to be repeated, it is necessary to think about corrective actions. You have to identify the source of the problem and think about a way to solve this problem. Present the result of your reflections to the healthcare team, the investigator and the CRA monitor, they will help you evaluate the feasibility of your idea and perhaps improve it.

Finally, you may identify a malfunction during the study but that have not yet led to a deviation. Perfect, however, again, we will have to think about preventive actions, to prevent this from happening in the future.

Here are some keys to help you avoid deviations from the protocol at best. It involves a lot of preparation, it may take a little time, but it is time that you will win afterwards. Did you know that some promoters do risk-based monitoring according to the center? Indeed, an automatic calculation taking into account several factors, including deviations from the protocol, to calculate the number of monitoring visits to be carried out on the center.

And you, what is your plan of action to avoid deviations from the protocol? Share your experience in the comments, maybe you will help other clinical site coordinators.

 On the same theme, you will find an article on the expectations of investigators with regard to clinical site coordinators.

A center with few deviations can help the recognition of the profession of Clinical site coordinator.