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Q of the week

Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Investigator and Investigator Site
  1. According to the ICH GCP what is the qualification for an Investigator?
    ICH-GCP does not insist on a particular medical qualification.
    ICH GCP 4.1 Investigator’s Qualifications and Agreements. 4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).
    In case of bio-equivalence study, US FDA guidance (Compliance Program Guidance Manual For FDA Staff Chapter 48 Bioresearch Monitoring Human Drugs In Vivo Bio-equivalence Compliance Program 7348.00) is as follows:
    The clinical investigator in a bio-equivalence study is involved in the screening and dosing of human subjects, and will ordinarily be a physician. Ph. D clinical pharmacologists and Pharm. Ds are acceptable if a physician is available to cover medical emergencies.
  2. To whom can the Principal Investigator delegate the duties in a clinical trial? Is he assign the duties to study team?
    Yes. If he/ she can demonstrate and document, that the person who is given the task has received such training.
  3. Is it allowed to a CRC to write source notes/hospital files at the site if principal investigator delegate that duty to them?
    Yes. This is allowed if the doctor is authorized by the investigator to do so. The investigator should ensure that the designated doctor is trained in completing source notes.
    An FDA guidance "Guidance for Industry Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators" discusses such issues. FDA cautions researchers on delegation of study tasks and advises that the investigators should be very careful in delegating clinical trial responsibilities.
    The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience to perform the delegated task.
    Appropriate delegation is primarily an issue for tasks that would be considered to be clinical or medical in nature, such as evaluating study subjects to assess clinical response to an investigational therapy (e.g., global assessment scales, vital signs) or providing part of the medical care provided to subjects during the course of the study. Most clinical/medical tasks require formal medical training and may also have licensing or certification requirements. Clinical investigators should take such qualifications/ licensing requirements into account when considering to whom it would be appropriate to delegate specific tasks. . The investigator is also responsible for overseeing the work of any staff members who are not directly employed by the site, such as employees of site management organizations.
    The investigator should ensure that staff:
    Have a general familiarity with the study and the protocol
    Have a specific understanding of the details of the protocol and the investigational product, relevant to the tasks they will be performing
    Are aware of regulatory requirements and acceptable standards for the conduct of clinical trials, both in respect to conduct of the clinical trial and human subject protection
    Are competent to perform the tasks that they are delegated
    Are informed of any pertinent changes during the conduct of the trial and educated or given additional training as appropriate
  4. Is it necessary for to take the informed consent from each subject personally by the investigator or it can be done by any other personal in the team?
    The clinical investigator is responsible for ensuring that informed consent is obtained from each research subject before the subject participates in the research study. The person who conducts the consent interview should be knowledgeable about the study and able to answer questions. ICH-GCP guidelines do not specify who this person should be. The investigator can designate any competent member of her team to conduct the process of obtaining consent. However, if someone other than the clinical investigator conducts the interview and obtains consent, the clinical investigator should formally delegate this responsibility and the person so delegated should have received appropriate training to perform this activity.
    It is not essential for the investigator to sign each form, if the consent is dated and signed by the person designated by her. However, some sponsors and some IRBs/IECs require the clinical investigator to personally conduct the consent interview. Hence, it is a desirable practice for the investigator to review and sign each consent form. The investigator remains ultimately responsible, even when delegating the task of obtaining informed consent to another individual knowledgeable about the research.
    The relevant guideline ICH-GCP 4.8.5 says: ‘‘The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject’s legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC.’’
    ICH-GCP 4.8.8: ‘‘Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject’s legally acceptable representative, and by the person who conducted the informed consent discussion.’’
  5. Is it requires mentioning the investigator name on the ICF as a contact person to answer the questions?
    ICH-GCP 4.8.10 requires contacts for questions about the research, the research subject’s rights and in case of a research-related injury. It does not specify whom to contact.
    The same person may be listed for all three. However, most IECs believe it is better to name a knowledgeable person other than the clinical investigator as the contact for study subject rights. Having the clinical Investigator as the only contact may inhibit subjects from reporting concerns and/ or possible abuses.

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Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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