General Consideration for the Clinical

Food and Drug Administration. (1977, September). General considerations for the clinical evaluation of drugs. Rockville, MD Author. 

General Considerations for the Clinical Evaluation of New Drugs (June 1992)... 

Food and Drug Administration. 1977. General Considerations for the Clinical Evahuition of Drugs. DHEW Publication No. (FDA) 77 3040. Washington. 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E8 Note for Guidance on General Considerations for Clinical Trials, CPMP/ICH/291/95. London European Agency for the Evaluation of Medicinal Products, 1997. 

This chapter considers the indications, precautions, and contraindications associated with the use of cyclo-plegics in refraction.The chapter also discusses such clinical topics as selecting the appropriate cycloplegic agent, administration techniques, procedures for refraction, and general considerations for spectacle prescribing. 

General Considerations for Clinical Trials. International Conference on Harmonization [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1997. http //www.ifpma.org/pdfifjpma/e8.pdf. 

And, including ICH standards, the General Considerations for Clinical Studies (April 1998)... 

In Europe, the European Commission (EC), through its Directorate General, DG III, responsible for trade including pharmaceuticals, and the Committee for Proprietary Medicinal products (CPMP), issued, on November 20 1996, draft notes for guidance, with a 6 month consultation period, on (a) non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95) and (b) general considerations for clinical trials (CPMP/ICH/291/95). Further revisons are expected. A directive on good clinical practices (GCP) will follow. 

Bowers GN, Bergmeyer HU, Horder H, and Moss DW (1980) Approved recommendations on IFCC methods for the measurements of catalytic concentrations of enzymes. Part 1. General considerations concerning the determination of the catalytic concentration of an enzyme in the blood serum or plasma of man. Journal of Clinical Chemistry and Clinical Biochemistry 18 89-95. 

Program 4.3 for creating study day variables for the SDTM data sets. However, the General Considerations document from the CDISC Analysis Data Set Modeling Team states that you should use the algorithm in Program 4.2 for analysis data sets. Whether you are deriving data based on the CDISC models or not, you should calculate study day variables in a consistent fashion across a clinical trial or set of trials for an application. 

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