According to the Good Clinical Practice “The Investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial…”, therefore proper training is an essential part of each clinical trial (study).
Trainings in clinical study could take different forms and approaches, but one of the most important delivery methods is an Investigator Meeting.
So, what is the Investigator Meeting? In simple terms it is a group meeting conducted by Sponsor or Contract Research Organization (CRO) on behalf of the Sponsor to train Investigators and their Site teams on the Clinical Study Protocol, related study procedures & guidelines etc. It is also a great opportunity for all study teams to get to know each other better and to have possibility to ask questions that might help in the future to make the study a success.
Apart from Investigator Meeting there are some more examples of Study Meetings which are briefly described below.
The aim of this article is to describe some peculiarities of organization, conducting & follow up of Investigator and other Study Meetings.
Before Investigator Meeting
First of all, the type of Investigator Meeting should be defined: whether it will be conducted in-person (face to face) or remotely. Organizational logistics & preparation approaches significantly depend on the chosen type.
In-person Investigator Meeting is the most traditional way of meeting that allows for face to face human-to-human interactions & networking possibilities. It is the most difficult from the organizational perspective, especially due to necessity of travel, but it allows to build strong relationships between Investigators/Site teams and Sponsor/CRO/involved study Vendors.
Remote Investigator Meetings are now becoming possible with the development of a vast array of technical capabilities allowing live online video/audio sessions, remote access to training materials, various quizzes/surveys & other forms of interactions. These types of Meetings have less organizational hurdles, but at the same time lack engagement as it is during in-person interactions.
In-person meetings are traditionally chosen in the onset of a particular clinical programme (a set of several clinical trials of certain pharmaceutical or medical device) or when a given clinical trial is of extremely high importance to the public health and/or of high complexity.
On the other hand, the remote meetings are usually conducted in the subsequent clinical trials of the clinical programme or for studies of predominately low complexity.
Irrespective of the chosen type, thorough preparation is required for a meeting to have great value & lasting impact on the study conduct (especially in identifying and recruiting eligible subjects).
Following below is a non-exhaustive list of major milestones to determine/consider when organizing Investigator Meeting:
· Meeting requirements (date[s], duration, attendee requirements)
· Translation requirements (if applicable)
· Meeting venue and travel logistics (including visa considerations)
· Necessary printed materials (e.g., presentation binders, handouts, pocket clinical study protocols)
· Necessary ancillary materials to be provided (e.g., badges)
· The invitation and attendee registration procedures
· Any other special requests (e.g., audio/visual, catering, and dietary requirements)
· Meeting budget.
Investigator Meetings are usually multi-national & cross-cultural bringing together highly diverse participants. Sometimes due to the above reasons and by taking into account the total number of attendees the Investigator Meeting could be split into two-three separate meetings organized in certain geographical regions.
During Investigator Meeting
Engagement of meeting participants is of utmost importance and everything should be done in order to keep it high.
All Investigators’ questions/requests & recommendations related to clinical study should be properly documented, tracked & answered as soon as possible.
Meeting organizer should ensure that all activities related to overcoming the possible language barriers (e.g., synchronous translations/interpreting) are fully functional and that each meeting participant has the possibility to freely speak out.
All Investigator Meeting participants should be provided with appropriate meeting materials including attendance confirmation at the conclusion of the meeting. Such materials should be kept in Investigator Site File as proof of received training.
Meeting organizer should professionally handle all issues/events occurring during the Investigator Meeting and promptly resolve & report them, if required.
After Investigator Meeting
It is of extremely high importance that all Investigators’ questions left unanswered after the conclusion of the meeting receive the written responses as soon as possible. This will allow to further keep engagement between Sponsor/CRO and Sites and let Investigators’ know that their opinion matters.
Reimbursement of incurred Meeting related expenses (if any) should be performed according to approved budget & respecting country-specific legislation.
All lessons learned during each Investigator Meeting should be identified, appropriately discussed, recorded and implemented for the future benefits.
Other Study Meetings with Investigator involvement
Sometimes during the study conduct there is a need to perform the additional meetings usually much less in scale, such as (non-exhaustive list):
· Recruitment related (so called ‘booster”) in case the enrollment of subjects is behind schedule or experiencing difficulties. During such meetings the inclusion/exclusion criteria are discussed and ways to improve (boost) recruitment are identified & agreed
· New Clinical Study Protocol related in case of issuance of significant study amendment(s) and introduction of new/changed study procedures
· Re-training related in case there is a need for a re-training involving several clinical study Sites or a particular participating country
· Intermediate meetings as a way to say “thank you” for great recruitment and high quality of obtained data
· Meeting at the end of the Clinical Study in case Sponsor would like to present results to Investigators.
Carpathian Research Group capabilities
Carpathian Research Group as a CRO provides the service of organization of Investigator and other Study Meetings and helps our Customers to keep engaged & motivated Site teams. Information on all other clinical trial services that we provide could be found at www.crg.global