{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:09:21Z","timestamp":1777543761029,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2012,1,5]],"date-time":"2012-01-05T00:00:00Z","timestamp":1325721600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:p>Background Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites.<\/jats:p>\n                  <jats:p>Purpose We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials.<\/jats:p>\n                  <jats:p>Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring.<\/jats:p>\n                  <jats:p>Conclusions The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.<\/jats:p>","DOI":"10.1177\/1740774511431280","type":"journal-article","created":{"date-parts":[[2012,1,6]],"date-time":"2012-01-06T06:10:26Z","timestamp":1325830226000},"page":"265-271","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs)"],"prefix":"10.1177","volume":"9","author":[{"given":"Julie","family":"M\u00e9thot","sequence":"first","affiliation":[{"name":"Department of Medicine, Universit\u00e9 de Montr\u00e9al and ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital, Chicoutimi, QC, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diane","family":"Brisson","sequence":"additional","affiliation":[{"name":"Department of Medicine, Universit\u00e9 de Montr\u00e9al and ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital, Chicoutimi, QC, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Gaudet","sequence":"additional","affiliation":[{"name":"Department of Medicine, Universit\u00e9 de Montr\u00e9al and ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital, Chicoutimi, QC, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2012,1,5]]},"reference":[{"key":"bibr1-1740774511431280","unstructured":"International Conference on Harmonisation (ICH). International conference on harmonisation, requirements for registration of pharmaceuticals, harmonised tripartite guideline (including E6: Guideline for Good Clinical Practice (GCP). 1996. Available at http:\/\/www.ich.org (accessed December 2011)."},{"key":"bibr2-1740774511431280","unstructured":"Food and Drug Administration (FDA). Running Clinical Trials, 2011. Available at http:\/\/www.fda.gov\/ScienceResearch\/SpecialTopics\/RunningClinicalTrials\/default.htm (accessed December 2011)."},{"key":"bibr3-1740774511431280","doi-asserted-by":"publisher","DOI":"10.1080\/08989620108573977"},{"key":"bibr4-1740774511431280","unstructured":"European Medicines Agency (EMA). ICH Topic E 6. Guideline for Good Clinical Practice, 2002. Available at http:\/\/www.ema.europa.eu\/ (accessed December 2010)."},{"key":"bibr5-1740774511431280","unstructured":"Medicines and Healthcare Products Regulatory Agency (MHRA). Good Clinical Practice: Frequently Asked Questions. Available at http:\/\/www.mhra.gov.uk\/Howweregulate\/Medicines\/Inspectionandstandards\/GoodClinicalPractice\/Frequentlyaskedquestions\/index.htm#T1 (accessed December 2010)."},{"key":"bibr6-1740774511431280","unstructured":"Fonds de la recherche en sant\u00e9 du Qu\u00e9bec (FRSQ). Standard Operating Procedures (SOP) to Ensure Good Clinical Practice at Clinical Research Sites, 2007. Available at http:\/\/www.frsq.gouv.qc.ca\/en\/financement\/SOP.shtml (accessed December 2010)."},{"key":"bibr7-1740774511431280","volume-title":"Practice Guidance on Pharmacy Services for Clinical Trials","author":"Royal Pharmaceutical Society of Great Britain","year":"2005"},{"key":"bibr8-1740774511431280","first-page":"190","volume":"7","author":"M\u00e9thot J","year":"2010","journal-title":"Biopreservation Biobanking"},{"key":"bibr9-1740774511431280","doi-asserted-by":"publisher","DOI":"10.1016\/S0197-2456(03)00074-6"},{"key":"bibr10-1740774511431280","doi-asserted-by":"publisher","DOI":"10.1093\/ajhp\/56.3.252"},{"key":"bibr11-1740774511431280","unstructured":"Minist\u00e9re de la Sant\u00e9 et des Services Sociaux. Les syst\u00e8mes automatis\u00e9s et robotis\u00e9s utilis\u00e9s pour la distribution des m\u00e9dicaments dans les \u00e9tablissements de sant\u00e9 au Qu\u00e9bec 2005. 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