Clinical trials documentation study drug

CRAs achieve these tasks through frequent visits to the clinical trial site. During these visits, the monitor will verify source data, audit regulatory documents for accuracy and completion, perform drug accountability assessments, and communicate any concerns, problems, or new information with the study staff. 

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

Experienced senior staff of the sponsor must always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in previous studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. Key questions will need to be answered relating to staff support and the present workload of the site. The competence of the staff to conduct any procedures, the maintenance, calibration and QC of any equipment to be used, and whether other clinical trials demand too much resource are aU questions that need answers. In addition, the facilities should be inspected to establish whether the site could store and securely archive the large amounts of documents and study drugs that will be present. The pharmacy may play a major role in the study and therefore the facility and the pharmacist should be visited. 

In addition to IRB members, the head of the institute must appoint a study drug manager, a document archiving manager and administration staff for both clinical trials and the IRB. In order to handle clinical trials in such a complex structure, SOPs for conducting clinical trials must be prepared at the hospital. 

Although BA studies have many pharmacokinetic objectives beyond formulation performance as described above, it should be noted that subsequent sections of this guidance focus on using relative BA (referred to as product quality BA) and, in particular, BE studies as a means to document product quality. In vivo performance, in terms of BA/BE, may be considered to be one aspect of product quality that provides a link to the performance of the drug product used in clinical trials and to the database containing evidence of safety and efficacy. 

Phase III Clinical Trials Consist of controlled and uncontrolled trials that are performed after preliminary evidence of effectiveness of a drug has been established. They are conducted to document the safety and efficacy of the drug, as well as to determine adequate directions (labeling) for use by the physician. A specific patient population needs to be clearly identified from the results of these studies. Trials during Phase III are conducted using a large... 

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