Research documents

Internal summary reports and formal proposals for management are often assembled in preparation for development milestones (e.g., candidate selection and full development decision). Research reports for critical data are written for products as they progress through development. However, reports for failing studies or discontinued programs are often not prepared and these can be equally useful since history tends to repeat itself. Because of the time and resources required to prepare such reports, a conscious decision should be made if the value added warrants the effort. 

Research reports are also emphasized in early development before regulatory documentation is required. However, recent changes with respect to reductions in the documents and extent of data that must be provided in IND submissions are increasing the importance of internal documentation through early clinical development (i.e., phases 1 and 2). Specifically, FDA guidances on IND CMC requirements have reduced the amount of data required for inclusion in the IND. Summaries are often allowed in lieu of detailed data. However, from both a compliance and historical perspective, it is critical to collect these data in a report for future reference. Thus, the documentation requirements overall have not been reduced but have been removed from the regulatory submissions and added to the in-house archives. 

Typical research documents include the following items  

There are three major types of analytical documentation prepared to support investigational and marketed pharmaceutical products  

Compliauce—including GMP documents (e.g., validation reports, investigation reports, and annual product reviews), internal reports (e.g., technology transfer reports), and special development reports (summarizing history of product or chronology of critical issues). Research—usually prepared to record or transfer product history (e.g., analytical profiles), additional informational studies, non-GMP batch issues and investigations. 

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Pusch, R. (1970). Clay microstructure. National Swedish Building Research. Document D8. 

Protocols to determine exposure scenarios should require that application be made using normal practices. Test substance application must be thoroughly documented by researchers. Documentation should include weights and volumes of materials added to... 

The following summary of acute effects in humans is based primarily on a review of the charts in the clinical files at Edgewood. Like many clinical records, these vary greatly in extent of detail, ranging from sketchy and Incomplete notes or one-line summaries to records that could serve as models for research documents. Independent chart reviews by NRC scientists provided some cross-checks on... 

The operability and reliability of processes using ammonia must also be studied. With the potential for increased ammonia use in these systems (in the selective catalytic reduction of nitrogen oxides and as an absorbent), research documenting ammonia emissions and the effects of ammonia on process equipment should be conducted. Furthermore, additional investigations should be performed to determine whether ammonium salts are formed and to document their effects on both the environment and the flue gas treatment system. 

I finish this part of my lecture with one more bit of information. Even with the increasing use of synthetic pesticides we still have as many pests as we did when we started in the 1940s, because pests can evolve resistance to the pesticides. This is because pests that can survive the treatment will grow and multiply. In 1991 researchers documented resistance to pesticides in over 500 insects and mites, 270 weeds, and 150 plant pathogens (Bellinger 1996). 

Morris, Jim, 1997. New alarm over hydrogen sulfide Researchers document lasting damage to human nervous system. Houston Chronicle, November 13. 

Several other procedures have been developed to protect unsaturated fatty acids from ruminal biohydrogenation. Of these, only the amide derivative has extensive research documentation (Jenkins, 1998, 1999), but has not been applied commercially. Often, calcium soaps of palm oil or canola fatty acids are referred to as protected. These are not protected from ruminal biohydrogenation (Table 2.2), but rather are ruminally inert with regard to their effects on the rumen microbial population. 

This document and trademark(s) contained herein are protected by law as indicated in a notice appearing later in this work. This electronic representation of RAND intellectual property is provided for noncommercial use only. Permission is required from RAND to reproduce, or reuse in another form, any of our research documents for commercial use. 

The cholesterol-lowering statin drugs, e.g. fluvastatin, improve the blood flow, probably by increasing the amount of nitric oxide in arterial linings and so helping them to dilate.2 (Do an internet search for nitric oxide to find recent research documents.)... 

Institutional review board records that do not adequately track or log research documents that have been submitted by the clinical investigator, including protocols, amendments, consent forms, Investigator Brochures, IND safety reports, advertisements, patient information sheets, and correspondence between the investigator and the IRB. 

A lack of approval notifications, approval notifications that do not adequately identify the research document (or the version of the research document) that has been approved, or missing dates of approvals. 

How are people exposed to PBTs Most of the public s exposure to chemicals such as mercury and dioxins is from food. However, INFORM research documented in 2000 that the majority of PBTs leaving factories leave in consumer products,... 

Ware, D.M., Tovey Hay, D., and McCarter, B. 2000. Straying rates and stock structure of British Columbia herring. Fisheries and Oceans Canada, Canadian Stock Assessment Secretariat Research Document 2000/006, 32pp. 

Guidance on Good Clinical Practice and Clinical Trials in the NHS, National Health Service, 1999. http //www.doh.gov.uk/research/ documents/gcpguide.pdf. 

Department of Health. GAfREC www.doh.gov.uk/ research/documents/gaffec.pdf. 

Compliance documents are needed, in addition to the regulatory and research documents, to demonstrate the integrity of the data. Compliance documents refer to those reports required by GMP and/or utilized during the course of inspection by a health authority (Chapter 15). 

The United States Government Office of Technical Services supplies information on government research documents. Some of these services have been described previously (26) and they are not discussed at this time. 

NR108-985. Arlington, VA Office of Naval Research. Document no. AD 044650. (authored by Martin and Hart). 

Gustafsson H. (1992) Building materials identified as major sources for indoor air pollutants a critical review of case studies. Swedish Council for Building Research. Document No. DIO 1992, Stockholm. 

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