Читать книгу Guide for Investigator Initiated Trials - Группа авторов - Страница 12
Оглавление7Qualifications, CVs of Site Staff, Training, Delegation of Authority
Before Initiation
To conduct a clinical trial, the sponsor-investigator and the study nurse must follow certain rules and the trial site must meet specifications, in accordance with GCP Guidelines.
The qualifications of the sponsor-investigator are as important as those of the trial site. The qualifications and the professionalism of the doctors and the non-medical staff involved are also relevant.
Regulatory Reference
! ICH GCP Guideline, Chapters 4.1, 4.2, 5.6, 5.7
! EU Directive 2001/20/EC, Art. 3.3
Responsibilities
To take part in a clinical trial, certain regulations are mandatory for the sponsor-investigator(s), the study nurse, and the trial site. Furthermore, all study staff must act in accordance to the GCP guidelines.
Sponsor-Investigator(s)
The sponsor-investigator must submit to the Ethics Committee his/her current curriculum vitae dated and signed, including name, office address, professional experience, other qualifications, completed studies, as well as education, training and qualifications, which are required by law.
see 14
Ethics
This verification of qualifications is important because the sponsor-investigator is responsible for the entire clinical trial and all clinical trial-related medical decisions.
see 4
Study Protocol
The sponsor-investigator must thoroughly know the exact protocol to implement the trial and must also understand the use of the product. The sponsor-investigator usually must provide proof of 2 years’ experience with clinical trials and GCP.
Another duty of the sponsor-investigator is to inform the trial subject about the study and to notify the family physician about the trial, if the subject so desires.
Study Nurse
The study nurse acts as an assistant to the sponsor-investigator. He/she must submit a topical CV, showing function and qualifications, including training and clinical trial experience.
Similar to the sponsor-investigator, he/she is obliged to act in accordance with the protocol and GCP.
The study nurse must be provided with accurate and detailed information about the trial (e.g. in dealing with SAEs, SUSARs and the obligation to notify the authorities).
The sponsor-investigator must explain and discuss any additional duties with the study nurse.
Study Site
To implement a trial successfully, the study site should also be chosen for optimal qualifications, such as supportive technical equipment, adequate facility for storage of the investigational product, suitable rooms and availability of appropriate equipment.
Additional key factors are the availability, experience and qualifications of emergency care staff, and/or the distance to another hospital with emergency care facilities.
The number of trial participants should not exceed the capacity of the study site.
Advice - Hints and Tips
• If you do not have GCP training yet, bear in mind that there are online systems available for distance learning.
• Use the ‘Delegation of Authority’ Form; it will help you with the delegation of the tasks.
• At all times, it is important to be knowledgeable about your proposed study, particularly with regard to the:
• Study protocol
• SAEs
• SUSARs
• Storage of investigational product and other documents
Forms and Templates
Curriculum Vitae/Qualification
Delegation of Authority
During Study
In general, an investigator is the person who is responsible for the conduct of the clinical trial at a trial site. He/she is also the responsible leader, if a trial is conducted by a team of individuals at the study site.
In an investigator-initiated trial, it is the sponsor-investigator who takes the ultimate responsibility for the trial. Consequently, he/she is responsible for a continual risk/benefit assessment and, furthermore, is the one who is able to stop or interrupt the trial if he/she cannot longer take the responsibility for continuation due to e.g. safety reasons.
Regulatory Reference
! ICH GCP Guideline, Chapter 4.3
Responsibilities
Sponsor-Investigator
The sponsor-investigator is responsible for a protocol-compliant trial and might decide to terminate or interrupt the trial due to specific reasons such as safety concerns identified during the course of the trial.
The sponsor-investigator is also responsible for the:
• IMP
• Indication under study
• Study management
• Handling of information/data
• Compliance with the study protocol
• Randomisation method
• Handling of SAEs and SUSARs
• Communication with Ethics Committee(s)
• Medical supply of the subjects
see 15
Trial Master File, Updating and Archiving
In addition, he/she needs to keep everyone up-to-date and must directly communicate accurate information.
The sponsor-investigator authenticates with a signature that he/she takes note of any new documents; therefore, documents can be inserted in an ongoing process.
Advice - Hints and Tips
If new physicians or assistants join the study team, they must be announced immediately to the Ethics Committee with their CV and other essential details.
see 14
Ethics
