Clinical trials documentation importation documents

Product specification documents and analytical test methods—In preclinical development, these are important documents and they evolve along with the development phases. Drug substances and products for clinical trials are tested based on these documents, and so are the stability samples. It is critical to ensure that the analyst will perform the right tests against the right specifications with the correct version of the test method. Therefore a mechanism must be in place to control these documents. This can be done manually or with TIMS. A manually controlled system would require the analyst to sign out hard copies of the documents from a central location. After the testing is done, the analyst would have to return these controlled documents to the... 

The scope of this book does not allow a discussion of all the requirements for GCE Readers are referred to Exhibit 6.7 for the headings in the relevant regulatory documents to gain further understanding of the requirements. Some important issues, however, are discussed to clarify the important aspects and requirements for clinical trials in accordance with GCP. Some of these aspects are ... 

Foreign drugs are required to have import registration. Foreign drug manufacturers and distributors file for examination and registration of their products with relevant data and documents. Clinical trials may need to be conducted based on evaluation by the Center for Drug Evaluation (CDE) (see Section 8.5). 

The Sponsor has to explain how the drug is to be manufactured, tested, and stored. TTie important criterion is to ensure that it is safe for the subjects of the clinical trials. The CMC is a living document it is updated as the clinical trials proceed from Phase I to Phases II and III and eventually to a licensed... 

The closing down of the clinical trial at the site after the last visit of the last study subject has finished and all the CRFs are completed is an important part of the clinical trial. The process of archiving the documentation, both at the site and at the sponsor office, needs to take place -ideally as soon as possible after the end of the clinical phase of the study. The effort required to do this well is very much less than that which will be required if deficiencies are identified later -particularly if that occurs during a regulatory authority inspection ... 

Many investigator sites employ part- or fulltime nurses to support the clinical trials. Nurses should never be considered to be an extravagance, because without them, the onus of administration and QC is solely on the investigator. The clinical trial nurse can help the investigator in many ways, but two of the most important are ensuring that the CRT reflects what is present in the source documents, such as essential events of the medical history of the subject, and close liaison with the sponsor s monitor. 

The importance of documenting internal processes in the form of SOPs has already been mentioned. Any activity forming part of the development plan is a process. Each SOP should be looked on as a dynamic document and opportunities for improving each process should be sought continually. For example, the time that elapses between the last patient completing a clinical trial and production of the statistical report is an activity very much on the critical path. 

While the issue of the ethical conduct of clinical trials in pediatric psychopharmacology is addressed comprehensively elsewhere in this book, it is important to present an FDA perspective on this important matter. It is also important to have the issue of ethics discussed in the context of the scientific needs for trials presented to the FDA in support of new drug applications. These trials must be adequate and well-controlled (U.S. Department of Health and Human Services, 2001). What this requirement essentially means is that, in order to support an efficacy claim, the trials must be interpretable and must be able to document efficacy. For treatments that are intended to improve symptoms, as is almost always the case for psychotropic drugs, placebo-controlled trials are the usual standard. This is especially true when there is a substantial failure rate in placebo-controlled trials for the drugs known to work in a particular therapeutic area, as again is the case for most psychotropic drugs. Where that is true,... 

The restenosis benefit is also intriguing, but, in all likelihood, has nothing to do with the antiplatelet actions of cilostazol, and may relate more to its effects on cytokine release from endothelial cells and smooth muscle cells, There is also preliminary evidence suggesting that cilostazol may speed the process of endothelialization (53). Again, with DES and their well-documented difficulties with endothelialization (54,55), this is a potentially very important future application that will require prospective testing in clinical trials. 

Age may be an important risk factor for the development of ADRs, and young children and the elderly may be particularly vulnerable. Despite this risk, documentation of ADRs in these groups is poor, and adverse reactions are often attributed to nondrug causes. Moreover, there is often inadequate experience with medications in these populations because they are often excluded from clinical trials (35). 

If adequate baseline measures do not exist, then an important part of the strategic plan will be to research and document the baseline burden of illness as it is currently being treated (or not treated, if this is the case). This can be done separately from the clinical trials that are taking place, although placebo-treated patient measures may also be... 

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