Information sheet, clinical trial

In the United Kingdom, the information sheet provided to the consenting study subject in a clinical trial sponsored by a pharmaceutical company will usually contain a reference to the clinical trial compensation guidelines of the Association of the British Pharmaceutical Industry (ABPI). It is not included in the information sheet of noncommercial studies. Study subjects taking part in clinical trials are not usually paid, unless it is... 

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

In conclusion, clinical trials have shown that COX-2-selective NSAIDs seem to be less toxic to the gastrointestinal mucosa than traditional ones. However, life-threatening ulcer complications have been reported in patients taking both celecoxib (81,96,97) and rofe-coxib (79). The FDA and other regulatory authorities require that drug information sheets for celecoxib and rofecoxib carry gastrointestinal ulcer warnings similar to those for older NSAIDs. 

The contents of a trial protocol should generally include the following topics. However, specific information may be provided in separate information sheets such as the IB. The clinical trial protocol briefly contains ... 

An adverse event is unexpected when its nature or severity is not consistent with information in the relevant source document(s) . Relevant source documents include the investigator s brochure for investigational drugs, and the master data sheet or core safety data sheet, or local product labeling for marketed products. The determination of whether an adverse event is unexpected usually resides with the company that sponsors the clinical trial or markets the product. 

The patient s informed consent was required by the old GCP, with a wording of in writing as a rule . A survey performed in the early 1990s showed that a limited number of informed consents were obtained in writing and the rest were in the form of verbal agreements without witnesses. There was concern about whether patients understood the nature of clinical trials because the informed consent sheet was rarely provided to the patient and, even if it was, the explanation might be too difficult for a layperson to understand. 

The FDA s Office of Device Evaluation, Center for Devices and Radiological Health, has developed a number of information sheets and guidance policies to help sponsors conduct clinical trials. IDE Memorandum D94-1 is particularly helpful. It contains an IDE Checklist for Administrative Review that sponsors can use to ensure that their IDE is administratively complete. Another important document is entitled Implementation of the FDA/ HCFA Intragency Agreement Regarding Reimbursement Categorization of Investigational Devices—IDE Memorandum D95-2. This memo establishes procedures... 

Source documents are composed of hospital records, office charts, laboratory data sheets, subject diaries, pharmacy dispensing records, recorded data from automated instruments, x-rays, etc. Source documents should be legible and should document that the subject is participating in a clinical trial. Some of the key areas to cross reference source documents to case report forms and regulatory criteria are the informed consent process, inclusion/exclusion criteria, adverse experiences, investigational product administration, concomitant medications administered to the subject during the trial, withdrawal from the study for any reason, and subjects lost to follow-up. 

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