Screening and Recruitment of Clinical Research Subjects

Introduction

Screening and recruitment of clinical research subjects are critical components of any clinical trial. Clinical trials are designed to evaluate the safety and efficacy of new treatments or therapies, and the success of these trials relies on the recruitment of appropriate participants who meet specific eligibility criteria.

The process of screening and recruitment involves identifying potential participants, determining their eligibility for the study, and obtaining their informed consent to participate. The success of recruitment efforts can significantly impact the quality and generalizability of study results, as well as the time and resources required to complete the trial.

Effective screening and recruitment strategies are essential for achieving study objectives and ensuring participant safety. The success of recruitment efforts often depends on the ability of the research team to engage with potential participants, communicate study information effectively, and address any concerns or questions they may have.

Moreover, the ethical and regulatory requirements surrounding the recruitment and participation of human subjects in clinical trials further emphasize the importance of robust screening and recruitment processes. These requirements ensure that the rights and welfare of study participants are protected, and that the study is conducted in a manner that adheres to established standards of scientific and ethical conduct.

Screening and recruitment of clinical research subjects is a critical component of any clinical trial. Effective recruitment strategies that prioritize participant safety, engagement, and adherence to ethical and regulatory requirements are essential for the success of any clinical trial.

Screening and Recruitment of Clinical Research Subjects

1. It is critical that the Investigator answers all staff questions about the interpretation of inclusion/exclusion criteria.
2. The Investigator should be able to devote time to the recruitment of suitable trial subjects; the consultation time for each subject will most likely be longer than the time required for normal consultation.
3. The Investigator must ensure that an adequate number of suitable study subjects are chosen unbiasedly in accordance with the Protocol.
4. The Investigator must give study subjects who meet the inclusion criteria the opportunity to choose whether or not to participate in the study.
5. The Investigator must document the identification of subjects who entered trial screening by completing a subject screening/enrolment log.

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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.

The study subjects must be given information on disease prevention and transmission for the duration of the trial. Before any subject enters a trial or any study-related procedures begin, written informed consent from the subject and/or his/her legally acceptable representative must be obtained. In the case of a screening test that necessitates the collection of biological specimens prior to entering a trial, two types of consent forms must be obtained: one for biological specimen collection and analysis, and another for participation in the study after satisfactory laboratory results meeting the inclusion criteria have been obtained. Subjects who are deemed ineligible for the study due to medical reasons should receive supportive counseling, any necessary and available treatment, and a referral for further counseling.

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:

1. 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.
2. 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.
3. 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.
4. The original signed and dated informed consent form should be kept in the Investigator's File with the study subject’s data.

Throughout the trial, trial subjects and/or their legally acceptable representatives should be kept informed of any new findings or information about the tested product that may have an impact on their participation in the trial. They should be provided with updates to the signed and dated consent form, as well as copies of any changes to the written information. The original signed and dated consent form, as well as any updates, should be kept in the Investigator's File.

Study Subjects Data and Documents For Clinical Research

1. All signed and dated informed consent forms (for enrolled and screened subjects).
2. Study subject screening and/or enrolment log.
3. Study subject identification list.
4. Copy of all Case Report Forms (CRFs).
5. Copy of the Serious Adverse Event form.
6. Copy of documentation of CRF corrections.
7. All study subjects source documents including laboratory results.
8. Copy of all subjects CRFs retrieval certificates.