For some strange reason, training looks like an unattractive offering, but in reality it is essential for every Sponsor/CRO conducting a trial, to offer ample training to their clinical trial site staff where the clinical trial would be conducted.
What is Study Specific Training?
Study Specific Training generally refers to training which is specific to a particular clinical trial that is going to be conducted at a clinical trial site. This usually includes training about the study protocol, any specific laboratory procedures, any specific CRF completion guidelines etc. Sponsors/CRO usually offer study specific training before the start of the study during the IM (investigator meeting) and SIV (site initiation visit). These trainings provide in-depth education into study/protocol specific issues and may also address few of the key points with regards to the regulations to be followed for the proposed the study. Study specific training (retraining) for the site staff also continues after the study is started if the clinical research associate finds out that the site staff is not performing well, or if a new site staff member joins the site team…
Who all are to be trained?
Training is provided to each member of the site, who would be involved in the study, starting with Principal Investigator (PI), Sub- Investigator (Sub-PI), Co-Investigator (Co-PI), Clinical Research Coordinator (CRC), Pharmacist, and staff nurse if involved in the study.
Discussion with PI and Co-PI:
Principal Investigators should be aware of the specific responsibilities that they must undertake while conducting a clinical trial. It is important to take the inputs of the PI and discuss the study design, research protocol, number of the patients to be enrolled into the study, inclusion-exclusion criteria, adequacy of informed consent, reporting of AEs and SAEs in a timely fashion as stated by the IRB and local regulatory authority etc. Also PI is the ultimate person responsible for administrative and scientific conduct of his/her research project.
For being investigators, an excellent way to gain experience in clinical trials is to be a sub-investigator. A sub-investigator is eligible to attend pre-study, initiation, and investigator meetings, all of which reinforce investigator responsibilities.
PI is expected to comply with all the requirements for the submission of continuing and final reports for the proper conduct of the research in compliance with the IRB, ICH-GCP or any other applicable regulations.
Study Specific Training to the Clinical Research Coordinator (CRC):
The good conduct of a clinical trial depends on how efficiently the CRC has been trained by the Sponsor/CRO in order to achieve the desired results in compliance with Good Clinical Practice, under the auspices of the PI. The CRC are usually trained on all the essential duties that have been conventionally performed by the PI, such as participating in the informed consent process while also ensuring compliance with the protocol. The CRC should also be specifically trained on the following: managing site and patient files, maintaining study logs, subject recruitment procedures and follow up, IRB submissions, timely AE and SAE reporting to the IRB and the sponsor, completing Case Report Forms (CRF), editing CRFs for corrections, data archival with reporting back to the sponsor throughout the study. It has been said “Although PI is responsible for the conduct of the trial it is the CRC who is the Heart and Soul of the research study”. It is the CRC who carries most of the burden and thereby playing a very significant role in the success of the study.
Study Specific Training to the Pharmacist:
A Pharmacist performs all the responsibilities which enhance the conduct of trial in an effective manner. A pharmacist is trained on the responsibilities such as coordinating, collaborating and providing expertise in support of clinical investigational drug trials; training study subjects about study drug administration and accountability; providing accurate and efficient dispensing of medication to the subjects; ensuring proper storage of the investigational drug as specified in the protocol; providing direct and/or functional supervision; maintaining overall responsibility for pharmacy operations in assigned area; performing communication responsibilities, maintaining daily temperature and humidity logs, maintaining all IP related logs etc.
Study Specific Training to the Staff Nurse:
The major responsibility of research staff nurse is to coordinate and supervise the clinical studies. An appropriate / proper training should be provided on the laboratory procedures involved during the screening, randomization, and follow-up visits of the subject. Also additional information should be provided during the training about the documentation of research, subject response to treatment, clinical expertise for protocol adherence and accurate data collection.
Site specific trainings for research staff is continuous process. As mentioned earlier, sometimes sites may be re-trained in case, if the Sponsor/CRO feels the need of doing so. For swift conduct of study it is necessary that the research staff is efficiently trained on the protocol procedures, SOPs (Standard Operating Procedures – if any) and applicable regulations in order to avoid any kind of unwanted pitfalls.