How to succeed your implementation visit?

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How to succeed your implementation visit?

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Written by Jena Chun.

As CRA monitor, one of your responsibilities is to ensure the site visits. You have among others : the implementation visit, the monitoring visits https://blogdelarechercheclinique.com/comment-reussir-sa-visite-de-monitoring/ and the closing visit.

Today we offer you to talk about the implementation visit. Have you ever had the opportunity to make one in your CRA career? In this article you will find some tips to best achieve this visit.

  1. What is an implementation visit?

Implementation visit aims to present to the principal investigator and his entire team (doctors, pharmacists, and nurses of Clinical Research (NCRs), CSCs … the study protocol and the information that they will find useful to include, to monitor patients and carry out the conduct the trial.

So you will need to prepare a presentation upstream, addressing the following points: protocol, the study objectives, study design (that is to say, the schedule of visits for the patient, with specific exams to be performed), or the studied product (s), the criteria for patient selection, the procedures for obtaining the consent, data and adverse events, etc. All this will be described  to you below.

This visit will also allow you to recover the necessary documents to begin the study: CVs (in English and / or French) dated and signed from various interveners of the study (those mentioned in the “Delegation log” or list of interveners on site), signed conventions, confidentiality agreements, etc.

  1. When should an implementation visit take place?

Implementation visit is mandatory. It must take place:

After obtaining all regulatory approvals (approval of the CPP and authorization of the competent authority ANSM, and possibly after obtaining CCTIRS and CNIL, according to the type of research), obtaining the certificate insurance by the Promoter and receipt of the signed financial agreements (hospital, investigators).

But before the implementation, you will have to ensure that the Hospital Directorate is informed (and the Pharmacy Department, if applicable) on the conduct of the research by promoter mail, that the site is selected, and the equipment has been sent, and all this, before the inclusion of the first patient in the study.

For the tests taking place at the hospital, an implementation visit to the pharmacy is also expected to manage treatment units. Depending on the type of study (phase IV + post-AMM), an implementation visit by telephone may be possible.

  1. How to prepare an implementation visit?

Before any action, consult with the guide of study monitoring. You will find information to help you in the preparation of this visit.

Then you will have to contact the investigator and his team, to agree on a date of implementation. Take this opportunity to specify the duration, the persons to be present, as well as the booking of a hall.

Importantly, make sure of the presence of the principal investigator, but also of all who will be involved in the clinical trial (NCRs, CSCs, pharmacists, radiologists, lab manager etc.). These interveners may intervene in obtaining the patient consent, inclusion and follow-up; filling and corrections notebooks observation and realization of complementary examinations.

Once the appointment fixed, we recommend you to send sufficiently in advance (by the deadlines set in the Monitoring Guide) a confirmation letter by mail and / or e-mail: This is to remind the agenda of the visit (place, date, time, program), the people expected and any required documents.

The day before your visit, think about making a phone call or send an email to confirm your coming (you never know! 🙂 ) and see with the center if they have received the necessary documents (investigator and pharmacy workbook, material of the study, treatment…).

Think to bring, during this visit, protocol, copies of blank forms (forms of delegation of tasks, of training in the study…), documents to be delivered to the site, the checklist of investigator workbook…and print multiple copies of your presentation, to give them to people who could not be present for the duration of the implementation.

  1. Once there, how does an implementation visit take place?

With your PowerPoint presentation, and as mentioned above, you have to address the following points:

  • The study protocol : justification of the study, the main and secondary objectives, evaluation criteria, criteria for inclusion and non-inclusion of patients, conduct of the study (estimated duration, schedule of visits, etc.)
  • The procedure for obtaining and collecting the consents
  • The procedures for inclusion: explanation of the study to the patient, time for reflection, signing in several copies of consent forms and patient information note (one handed obligatorily to the patient), possibility of withdrawal from study at any time.
  • Product to study: methods of dispensing, preparation, recovery and accounting
  • The samples to be taken, their storage, their preparation and their sending and laboratories involved in the study
  • The mode of collection, filling and correction of data on paper or via electronic CRF
  • The EIG and their reporting procedures
  • The management of discontinuing treatment, of un-blinding and study trips
  • The role and responsibilities of each team member
  • Monitoring visits: frequency, duration and course
  • The study workbook (center / pharmacy), its content and archiving rules
  • The other procedures and documents related to the study.

After the presentation made, take the time to answer each questions of the team. If you do not have answers to give, do not panic, say simply that you will find out about it and will get back to them.

Take good notes during the visit, this will help you save time when writing the report 🙂

Benefit from the presence of the investigator and his team to make them sign the monitoring register, the delegation form of tasks … but also to retrieve the documents that you miss.

Think to verify that the center has the necessary documents for the study, and in the correct versions! Consent forms, patient newsletter, protocol or investigator brochure or RCP, etc.

One last tip, think to check equipment and products in the study received by the center, do not forget to sensitize the team to the opportunities for audit and inspection and remind them the publications rules of the promoter.

  1. What next?

After doing all that, you have to write the implementation visit report (in English or French according to the procedure of the promoter), send the follow up letter and update your monitoring tools. Do it as soon as you can, as it’s fresh 🙂

If you have other experiences or tips to share, thank you to let us know in the comments! 🙂

Recherches utilisés pour trouver cet article :exemple mail de mise en place recherche clinique,Préparer une visite de mise en place essai clinique,visite de mise en place apres l avis cpp
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Elias
Elias
1 année il y a

Bonjour

On m’a souvent demandé de vérifier la liste de délégation des tâches lorsqu’un nouvel intervenant est impliqué dans l’étude (Nouvel ARC, nouvelle infirmière….). Mais pas le site training log.
Le site training Log n’est utilisable que lors de la mise en place ? Qui forme , un autre membre du personnel et dans ce cas c’est lui qui signe?
Pour les nouveaux co-investigateurs est ce valable si un membre de l’équipe les forme?

Merci par avance

Vanessa Montanari
1 année il y a
Reply to  Elias

Bonjour,

Oui,il faut vérifier la training log tout au long de l’étude, les auditeurs le font :).
La personne qui forme peut-être un membre de l’équipe d’investigation, s’il a déjà été formé lors de la mise en place ou alors l’ARC promoteur. Tout dépend de la formation à faire et de la complexité.
Pour un nouveau co-investigateur, le mieux est l’investigateur principal.
Merci,

Vanessa