Wednesday, December 29, 2010
Screening and Recruitment of Study Subjects in Clinical Research
It is important that the Investigator resolves all questions from his/her staff concerning the interpretation of inclusion/exclusion criteria.
The Investigator should be able to dedicate time to the recruitment of suitable trial subjects – the consultation time for recruitment of each subject is likely to be longer than the time required for normal consultation.
The Investigator must ensure the unbiased selection of an adequate number of suitable study subjects as defined by the Protocol.
The Investigator must allow study subjects who meet the inclusion criteria the opportunity to decide for themselves whether or not to be entered into the study.
The Investigator must document the identification of subjects who entered trial screening by completing a subject screening/enrolment log.
Obtain Informed Consent from All Trial Subjects
The concept of obtaining informed consent is considered to be the heart of GCP. Informed consent is the process by which a study subject voluntarily confirms his/her willingness to participate in the trial. Only study subjects who have fully understood all aspects of their participation in the trial can make proper judgements and give their consent to participate in the trial.
Information on disease prevention and transmission must be provided to the study subjects for the whole of the trial period. Before any subject enters a trial, and before any study-related procedures begin, written informed consent must be obtained from the subject and/or his/her legally acceptable representative. In the case of a screening test which requires biological specimens to be collected prior to entering a trial, two types of consent form must be obtained, one for biological specimen collection and analysis, and the other for participation in the study after satisfactory laboratory results respecting the inclusion criteria have been obtained. Study subjects found ineligible at screening (for medical reasons) should receive supportive counselling, any necessary and available treatment and referral for continued counselling.
The Investigator can delegate the consent process to an appropriately qualified person; however, the Investigator should see the subject afterwards to ensure that the consent has been properly
obtained. Verbal and written information given to the trial subject should be in simple terms and in his/her first language. Medical terms should be avoided.
The Investigator/designated person should perform informed consent procedures fully with each subject during recruitment:
Ø The informed consent form should be personally dated and signed by the trial subject and/or his/her legally acceptable representative as well as the Investigator/designated person responsible for the informed consent procedures.
Ø If the study subject and/or legally acceptable representative is (are) unable to read, an impartial witness for the Investigator should be present during the entire informed consent discussion. After oral approval by the study subject and/or legally acceptable representative, the witness must sign and personally date the informed consent form and attest that the information was accurately explained and apparently understood, and that informed consent was given freely by the subject and/or legally acceptable representative. The subject and/or legally acceptable representative should personally sign and date the form if capable of doing so.
Ø The study subject and/or legally acceptable representative should be given a copy of the signed and dated informed consent form and any other written information.
Ø The original signed and dated informed consent form should be kept in the Investigator's File with the study subject’s data.
Trial subjects and/or their legally acceptable representatives should be kept informed throughout the trial of any new findings or information about the tested product which might be of consequence to their participation in the trial. They should receive updates of the signed and dated consent form as well as copies of any amendments to the written information. Updates of the original signed and dated consent form should be kept in the Investigator's File.