Informed Consent, Trial Records And Data Handling

GCP was developed to both provide a unified international standard for conducting trials involving human subjects and to supply guidelines regarding the appropriate reporting of data obtained through the course of such clinical studies.

Good Clinical Practices (GCP) is a set of guidelines developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). These guidelines take into account established clinical practices from several regions worldwide. It was developed to provide both a unified international standard for conducting trials involving human subjects and to supply guidelines relevant to the appropriate reporting of data obtained through the course of such clinical studies.

The ICH GCP Guidelines are based on several key principles with the rights and safety of the trial subjects always at the forefront of importance.

Key Principles

For a trial to be initiated, the foreseeable risks should always be compared against the potential benefits. In addition, there should be sufficient nonclinical and clinical information on the investigational product to support the study. The trial and its associated activities should be clearly described in a detailed protocol which should be approved by the institutional review board (IRB) or independent ethics committee (IEC). It is also essential that informed consent is obtained from each subject before the trial begins.

Throughout a trial, any medical care that is given to subjects should be by a qualified physician. Appropriate systems and procedures must also be implemented to ensure the quality of each aspect of the trial. It is required that the investigational products be manufactured, handled, and stored by Good Clinical Practices (GCP) to guarantee the quality compliance of the trial and the safety of the subjects.

Informed Consent

By Good Clinical Practices (GCP) principles, the written informed consent form should be approved by the IRB or IEC before the trial begins. Certain guidelines should be followed for any written or oral information provided to the subject, or the subject’s legally acceptable representative, during the informed consent process. The investigator is responsible for fully informing the subject or their representative of all aspects of the trial. The language used when providing the information should not cause the subject or their representative to waive any legal rights, and should be sufficiently non-technical to be understandable by the subject or their representative.

Sufficient time and opportunity must be given to the subject, or their representative, to inquire about the trial. If the subject decides to participate, the informed consent form should be signed and dated by them, or their representative. It must also include the signature of the individual who conducted the informed consent discussion. It must be ensured that the subject is not coerced, in any way, to participate in the trial.

In case new information is obtained that could be relevant to the subject’s consent, appropriate revisions should be made to the informed consent form or any other written information that is provided to the subjects. The revised informed consent form should also be reviewed and approved by the IRB or IEC before being used. The new information must be communicated to the subject, or their representative, promptly.

Records & Reports

The GCP guidelines also provide direction for appropriate record keeping. All information associated with the trial should be recorded accurately and handled in a manner that allows it to be interpreted appropriately. It should also be guaranteed that records containing information about subjects are kept confidential, in order to protect the identity of the subjects.

For each trial, the investigator is expected to maintain accurate source documents and trial records, which will include all important observations of each subject participating in the trial at each site. The data from these source documents are reported in the case report form (CRF), and must be consistent throughout. It is the investigator’s responsibility to ensure that the data in the CRF and all other required reports are complete, accurate and legible, and reported to the sponsor in a timely manner. Any changes or corrections to the CRF should be dated, initialed, and explained, ensuring that the original entry is not obscured.

Trial documents should be maintained as specified in the guidance on Essential Documents by the ICH, and according to any other applicable regulatory requirements. Essential Documents are those that enable evaluation of the conduct of a study and the quality of the data produced. Due to the importance of this documentation, the investigator should take all needed measures to prevent the destruction of these records.

Data Handling

The Good Clinical Practices (GCP) guidelines also provide direction for appropriate record keeping. All information associated with the trial should be recorded accurately and handled in a manner that allows it to be interpreted appropriately. It should also be guaranteed that records containing information about subjects are kept confidential, to protect the identity of the subjects.

For each trial, the investigator is expected to maintain accurate source documents and trial records, which will include all important observations of each subject participating in the trial at each site. The data from these source documents are reported in the case report form (CRF) and must be consistent throughout. It is the investigator’s responsibility to ensure that the data in the CRF and all other required reports are complete, accurate, and legible and reported to the sponsor promptly. Any changes or corrections to the CRF should be dated, initialed, and explained, ensuring that the original entry is not obscured.