Documentation study drug

Some fail to document and report what they should clearly recognize as an ADR. Some are so "invested" in the study drug, believing so strongly in its safety, that their enthusiasm overshadows sound scientific and regulatory sfandards. 

Discussion This was first adequately documented study of the exposure of military volunteers to BZ. More extended baselines were used, as well as scheduled observations at 1, 2, 3, 4, 5, 6, 10, 24, 48 and 72 hours after administration of the drug. Vital signs and neurological status were recorded at approximately the same intervals. The examining physician recorded mental status changes whenever they occurred. The data were less than optimal due to the infrequency of observations after 10 hours, as well as the brevity of written records of behavioral changes. 

Return shipping documents indicating what study drug went back to sponsor or destruction certificate indicating what was destroyed at site (once study has started)... 

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. 

Documentation should be available showing what is stored in the pharmacy or investigator s study drug cupboard, what has been administered to the subject and what has been returned in the form of leftover study drug or empty containers (see Box 7.3). In addition, there will... 

Box 7.3 Documents present in master files concerning the study drug(s)... 

Document (may be in protocol or investigator s brochure) with full details of study drug including details of stabihty, method of destruction, etc. 

Receipt of study drug and decode documents signed and dated on receipt... 

Frequently, in early trials of a new study drug, the expiry date is extended as more stability data become available. Any additional labelling by the sponsor or by the investigator should be documented fully and, where possible, a second person should (2C the process. The labelling should always meet the GMP regulations applicable in the location. 

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. 

The length of time required to archive the documents is at least 2 years after the last approval of the marketing application or any contemplated marketing application, or at least 2 years after the formal discontinuation of clinical development (ICH GCP 5.5.11). These requirements make long-term planning for archiving difficult because usually one does not know what the status of the study drug will be in 6 months time, and certainly not in 2 or 3 years. 

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. 

The results of a similar study of ours, in which the study drugs were three atypical neuroleptics or antipsychotics, are given in Table 5-4. During the time of this study, clozapine, olanzapine, and risperidone were the only atypical neuroleptic or antipsychotic agents in general use at HCPC these three drugs were selectively used in accordance with the clinical criteria set by the Harris County Mental Health and Mental Retardation Authority. These criteria included documentation of at least two failures to respond clinically to treatment with different typical neuroleptic agents. 

Study drug receipt, return and accountability documentation... 

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