The process for assessing feasibility all starts from the very beginning – from receiving a request for a study. This is an important stage at which the center receives a request from a potential customer, a CRO or pharmaceutical company, about the possibility of conducting a certain clinical trial in this site. These are the things that are most important at this stage:
First comes compliance with the deadlines for filling out the questionnaire, no matter the form – paper or electronic. Completion deadlines are provided either by the customer or set by the center itself (in the form of a separate SOP). The terms can be different – from 24 hours to 7 days. At the University, we made it our mission to complete the questionnaire within 48 hours of receiving it. There is a well-known phrase in marketing – “You will not get a second chance to make a first impression” – and it fits here completely.
A quick response to the request shows your interest in cooperation “in principle”, which is extremely important. Either the administration at the site, or the investigator can receive a request. There is no global difference in this, but the administration will likely delegate the completion of the questionnaire to the investigator, which is correct since they would know the answers to specific questions. Or it can be “joint creativity”, where the investigator fills in specific parts; related to patients, laboratory, instrumental examinations, and the administration addresses questions involving the terms of contracts, the work of the Ethics Committee (EC), and so on. Together with the questionnaire, the site also receives a “confidentiality agreement”. This document is quite formal and as a result the process of signing it at the site should be as simple as possible. The procedures of the site should specify who has the right to sign such agreements – the investigator or a representative of the administration responsible for this area of the clinic’s activities. The signing of this agreement is best done immediately upon receipt, so as not to delay the entire process.
Write truthful information. Indicating a “favourite” number regardless of the nosology, whether it is gastritis or one of the orphan conditions, is not quite the right approach. Firstly, this is not a “shop all at the same price”, and secondly, companies form recruitment plans based on the data obtained from the questionnaires. If a site provides false data, then they can substitute the project team, and not just the site. And then the question arises if the project team would want to work with such a site in the future.
One more conclusion can be drawn from this – the center needs to keep statistics on nosologies. In accordance with the general trend towards digitization, including electronic medical records, this data resource will only develop. Another issue is the quality of this database and the volume of its filling. It is logical that the diseases be coded according to one or another classification (firstly ICD), so that not only is the main diagnosis coded, but also concomitant ones with the possibility of filtering by years. Some investigators keep their databases in a conditional “excel”. In principle, this does not change anything, as the main thing is that the statistics be representative. In international studies, this data also forms the basis of regional enrollment planning for several countries.
Scientific advice to improve the protocol
Request for “scientific advice” from the study sponsor on study design and protocol. Of course, this does not always happen, and often it is only with large academic sites. We are talking about consulting from the site (represented by academicians, professors and investigators) with the company about the possibility of conducting a specific study with a specific design, sometimes at a specific site. In my experience, several times the investigators of the University made corrections to the already written synopses of the protocols. The main reason for such changes is that protocols are written mainly by medical writers who may often not have a completely correct idea of the work of a doctor with a patient. Such cooperation is very useful for all participants in the process, and the sponsor reduces their risks due to the impossibility of conducting a study, while the site feels its scientific significance, authority and trust in its opinion.
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General admin & documentation
Collection of documents from the center, would involve the CVs of the principal investigator, team members, head of the laboratory and SOPs, usually EC. From a systems/managerial point of view, it is better that such documents be kept in the appropriate administrative unit responsible for organising research at the site. It makes sense to update CVs once a year, because during this time the section on experience in research/trials, publications will increase and the specialist certificate number may be updated. The practice of requesting copies of diplomas and specialist certificates is a thing of the past. Globally, it is not very significant, but it shows the fundamental attitude of the site to documentation and interest in participating in trial.
A few more important documents that may be requested at this stage are equipment verification documents, waste disposal documents and laboratory standards. Verification must be carried out by the appropriate authorised organisation, with the issuance of an official document. It does not cost a lot of money or administrative labor hours to organise the verification of equipment. This task is purely technical. As for waste – as a rule, if a medical organisation does not deal with this itself, but hires a vendor, then, there should be a documentary trail for work in this direction. Particular attention is paid to the possibility of recycling waste of different classes. Laboratory standards must be dated and signed by the head of the laboratory. For general convenience, all these documents (or copies thereof) should be kept in the unit responsible for organising research.