Essential Documents for Clinical Trials
In this article we wish to present a brief review of study essential documents that most often require translation during the course of a clinical study. We hope this article will be useful to those who, due to their activities, deal with translation of materials for clinical studies.
The essential documents for clinical trials are the following:
Now, let us consider in more detail these documents:
INVESTIGATOR'S BROCHURE (IB):
Contains pre-clinical and clinical information related to an investigational drug. The information should be presented in a concise, simple, objective, balanced form that should be taken into account during translation.
The Investigator's Brochure includes Title Page, which provides the Sponsor's name, the identity of investigational product (products), an edition number and date, and the number and date of the edition it supersedes as well. The Sponsor may wish to include a Confidentiality Statement instructing to treat the IB as a confidential document. A standard Investigator's Brochure usually includes the following sections:
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
CLINICAL STUDY PROTOCOL
After the objectives and design of a clinical study have been determined, these issues should be documented in the Study Protocol. The Study Protocol is a document containing instructions for all the parties involved in the clinical trial that establish specific objectives for each participant and provide guidelines for their performing.
The following sections should be included in the Study Protocol:
The following appendixes may be included in the Study Protocol: Patient Information Sheet/Written information and/or Informed consent form (ICF). Instruction sheet (e.g. for study subjects or study site staff).
The terms, which may be difficult for understanding by study subjects (both medical and law terms) should be avoided in translation of the abovementioned documents containing patient information. If special terms are used in the documents, they should be clarified or explained.
Protocol amendment describes major changes to the initial Study Protocol. Protocol amendment must be again approved by the Ethics Committee.
Informed consent is one of the most important elements of system ensuring the ethics of medical experiments and protection of the rights of the study subjects.
Informed consent is a process by which a subject voluntary confirms his/her willingness to participate in one or another clinical trial, after having been informed of all aspects of the study. Informed consent should be documented by means of a written, signed and dated Informed Consent Form (ICF).
Potential subjects should be informed of the objectives and methods of the study, the drug product and treatment regimen, the available alternative treatments, potential risks and benefits, and of possible complications and discomforts, which may arise from participation in the study.
Based on information that he/she had received and understood, the potential subject freely gives consent to participate in a study. The informed consent should not be obtained through inducement or coercion. The subject should be aware that he/she may withdraw from the study at any time, and this will not affect his/her future medical care in any way.
The main principles of Informed consent
The subject should be informed of the following:
The subject should understand:
STUDY PROGRESS REPORTS
The Investigator should provide written reports on study progress to the Ethics Committee. These may be the Interim report on the interim results of the study and their assessment based on the analysis conducted in the course of the study, or the Final report - full, comprehensive description of the study including description of investigational materials, study design, and presentation and assessment of results of statistical analysis. Additionally, the Investigator should prepare the written reports on all major changes that might affect study conduction and/or increase risk to study subjects. These are the following: Adverse Event Report or Adverse Drug Reaction Report, Patient Entry Form(Patient Entry Card/Patient Notification Form) and Patient Withdrawal Form, Protocol Deviation/Violation Report, Study Termination Report etc.
Reporting on study progress is not only responsibility of the Investigator, but also the Study Monitor should provide the written reports on each Study Monitoring Visit (Monitor Report). The Expert Report is prepared for the regulatory authorities by an expert in the appropriate field (company officer or independent person) and covers different aspects of drug development.
CASE RECORD FORM (CRF)
Case record form is a paper or electronic document designed to record all the information for an individual study subject required by the Study protocol.
The Case record form is used for several purposes:
The data collected in the study site during the course of a study should be comprehensive and provide true and fair information on what happened to each study subject. Only if the above criteria are met, the study will reliably answer the questions concerning the efficacy and safety of the investigational drug.
All CRF's should include the following data:
Additionally, the CRF's should include special pages to record the following information:
All CRF's should be legible and suitable for duplication and possible additional sharing.
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