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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.
Informed Consent and Patient Information Sheet
  1. Is it acceptable to consent from the staff member of the hospital since the patient and his legally acceptable representative are illiterate?
    No. A staff member of the hospital even if he/ she is not connected with the trial, can't become a witness. The witness has to be independent of the trial. The witness should be a person who cannot be influenced by the investigator and his team.
    The staff member from the hospital will not be an impartial witness as he is likely to be influenced by the investigator or his staff. The relevant definition from ICH-GCP is cited below:
    ICH GCP 1.26: Impartial Witness: ‘‘A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject
  2. If a patient is signed on the informed consent but there was no date on it, is it acceptable to enter the date by the study coordinator?
    As per GCP guidelines, the patients must date their signature on the ICF. The study coordinator should have checked the ICF for completion when the patient returned the same. Routine checking of documents would have prevented this problem.
    The study coordinator cannot date the ICF. At the next visit, the patient should be requested to write a note on the ICF explaining the omission of the date, and entering their signature and current date. (eg., ‘‘I agreed to participate in the study and signed the consent form on 1 Aug, ’03 but forgot to put the date on the consent form at that time. Signature and date of note).
  3. Is it necessary to provide the contact information of the site and investigator in vernacular language if the Informed Consent Document is given in vernacular language?
    The objective of the contact information is to facilitate the patient in case of any issues about the trial. Hence, the contact information should be in vernacular language
  		 


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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