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Experiences with GCP in the pharmaceutical industry [corrected].
Methods Find Exp Clin Pharmacol. 1993 May; 15(4):237-40.MF

Abstract

The Declaration of Helsinki and the "new" Germany Drug Law of 1976 may be regarded as the first and all important step in the evolution of Good Clinical Practices (GCP) in Germany. "Regulations on the orderly conduct of clinical studies" (published in 1987), reflecting most elements of the GCPs, caused the German industry to make provisions for more successful drug approvals in the future. Pharmaceutical companies have improved their documentation systems with regard to study protocols and reports, increased their monitoring capacity, and began setting up SOPs. In preparation for the issuing of the E.C. GCP guidelines companies established Clinical Quality Assurance (CQA) units responsible for various CQA tasks such as training of monitors and investigators, auditing of protocols, reports, systems, and data. Typical problems connected with the implementation of GCP in Germany appear to be contradictory opinions of the various ethics committees, reluctancy on the part of investigators to assume additional bureaucratic workload, difficulties on the part of the sponsor resulting from the high financial and manpower requirements, as well as the relatively unfavorable political and public opinion of clinical research. The benefits achieved by the introduction of GCP are already visible, i.e., increased quality of study protocol, conduct and report of studies, reduced number of studies, transparency at all stages of clinical research and increased ethical awareness.

Authors+Show Affiliations

Bayer AG, Medical Department Germany, Wuppertal.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

8240533

Citation

Rämsch, K D.. "Experiences With GCP in the Pharmaceutical Industry [corrected]." Methods and Findings in Experimental and Clinical Pharmacology, vol. 15, no. 4, 1993, pp. 237-40.
Rämsch KD. Experiences with GCP in the pharmaceutical industry [corrected]. Methods Find Exp Clin Pharmacol. 1993;15(4):237-40.
Rämsch, K. D. (1993). Experiences with GCP in the pharmaceutical industry [corrected]. Methods and Findings in Experimental and Clinical Pharmacology, 15(4), 237-40.
Rämsch KD. Experiences With GCP in the Pharmaceutical Industry [corrected]. Methods Find Exp Clin Pharmacol. 1993;15(4):237-40. PubMed PMID: 8240533.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Experiences with GCP in the pharmaceutical industry [corrected]. A1 - Rämsch,K D, PY - 1993/5/1/pubmed PY - 1993/5/1/medline PY - 1993/5/1/entrez SP - 237 EP - 40 JF - Methods and findings in experimental and clinical pharmacology JO - Methods Find Exp Clin Pharmacol VL - 15 IS - 4 N2 - The Declaration of Helsinki and the "new" Germany Drug Law of 1976 may be regarded as the first and all important step in the evolution of Good Clinical Practices (GCP) in Germany. "Regulations on the orderly conduct of clinical studies" (published in 1987), reflecting most elements of the GCPs, caused the German industry to make provisions for more successful drug approvals in the future. Pharmaceutical companies have improved their documentation systems with regard to study protocols and reports, increased their monitoring capacity, and began setting up SOPs. In preparation for the issuing of the E.C. GCP guidelines companies established Clinical Quality Assurance (CQA) units responsible for various CQA tasks such as training of monitors and investigators, auditing of protocols, reports, systems, and data. Typical problems connected with the implementation of GCP in Germany appear to be contradictory opinions of the various ethics committees, reluctancy on the part of investigators to assume additional bureaucratic workload, difficulties on the part of the sponsor resulting from the high financial and manpower requirements, as well as the relatively unfavorable political and public opinion of clinical research. The benefits achieved by the introduction of GCP are already visible, i.e., increased quality of study protocol, conduct and report of studies, reduced number of studies, transparency at all stages of clinical research and increased ethical awareness. SN - 0379-0355 UR - https://www.unboundmedicine.com/medline/citation/8240533/Experiences_with_GCP_in_the_pharmaceutical_industry_[corrected]_ DB - PRIME DP - Unbound Medicine ER -