{"doi":"10.1016/j.conctc.2021.100859","title":"Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial","abstract":"Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. The study enrolled 2629 women at 15 clinical research sites in Malawi, Uganda, South Africa and Zimbabwe who were randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a matching placebo vaginal ring. The vaginal rings and packaging were identical in appearance in order to maintain the study blind. A real-time, documented second check of the dispensing process was conducted by a second pharmacy staff. Frequent inventory counts and real time accountability audits were also useful for rapidly identifying a dispensing error. A total of 52,625 vaginal rings were dispensed with only three documented pharmacy dispensing errors. There were zero dispensing errors at 13 of the 15 sites with an overall rate of <1.0 per 10,000 rings dispensed. Our study findings support the implementation of a double check dispensing process and real time accountability audits as standard practice in clinical trials.","journal":"Contemporary Clinical Trials Communications","year":2021,"id":212367,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9508,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":802665,"name":"Jayajothi Moodley","orcid":"0000-0001-5550-9822","position":1,"is_corresponding":false},{"id":634598,"name":"Aruna Bhoola","orcid":"0000-0003-3202-8625","position":3,"is_corresponding":false},{"id":803088,"name":"Rebecca Sakwa","orcid":null,"position":4,"is_corresponding":false},{"id":803089,"name":"Jeeva Moodley","orcid":null,"position":5,"is_corresponding":false},{"id":803090,"name":"Jasmin Lynn Sukdao","orcid":null,"position":7,"is_corresponding":false},{"id":803091,"name":"Nivriti Hurbans","orcid":null,"position":8,"is_corresponding":false},{"id":486706,"name":"Bhavna Maharaj","orcid":"0000-0003-1935-4637","position":9,"is_corresponding":false},{"id":802666,"name":"Anushka Naidoo","orcid":"0000-0001-9550-9501","position":10,"is_corresponding":false},{"id":803092,"name":"Melanie Maclachlan","orcid":null,"position":11,"is_corresponding":false},{"id":385782,"name":"Gift Chareka","orcid":"0000-0002-0529-877X","position":12,"is_corresponding":false},{"id":802667,"name":"Kudzai Hlahla","orcid":"0009-0006-9052-6488","position":13,"is_corresponding":false},{"id":803093,"name":"Mary Chadza","orcid":null,"position":14,"is_corresponding":false},{"id":634592,"name":"Cindy Jacobson","orcid":"0000-0001-9638-7665","position":0,"is_corresponding":true}],"reference_count":6,"raw_metadata":null,"created_at":"2026-07-18T23:52:27.434608Z","pmid":"34825101","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}