Statistical Center for HIV/AIDS Research and Prevention (SCHARP)

SCHARP supports a comprehensive range of infectious disease clinical trials, covering every stage of the research and development lifecycle — from preclinical (phase 0) studies through phase 3 trials. We also provide specialized support for observational studies, hybrid designs and pilot or vanguard studies. These small-scale, preliminary trials assess the feasibility of participant recruitment and retention, the feasibility and acceptability of interventions, and the incidence of infectious diseases in targeted populations.

CDISC, an international organization that defines data standards for clinical research, has various data models that serve different operational purposes. CDISC Standards are now required for regulatory submissions to the U.S. Food and Drug Administration, and they must be considered at all stages of the clinical study lifecycle – from the design of compliant CRFs through the specification of the final data displays.

Yes. The three that are most relevant to the work done at SCHARP are Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

SCHARP designs study CRFs using CDASH principles with the future production of SDTM and ADaM in mind. SCHARP routinely generates a selection of SDTM- and ADaM-aligned datasets as needed for various operational functions throughout the course of a trial. The use of these CDISC-aligned datasets permits SCHARP to manage data and provide standard operational reporting more efficiently and effectively over the course of the ongoing trial. SCHARP tailors the production and use of CDISC-compliant datasets and supporting materials to meet the unique needs of each individual trial, but does not routinely produce a fully-compliant, submission-ready package for every study.

SCHARP can provide the CDASH-aligned CRF page level datasets or any SDTM+/- domains or ADaM+/- datasets and the associated metadata that we routinely generate for trial operations or interim or final reporting to a sponsor or partner as a supplement for them to complete any submission-ready packages themselves or through a contract with a third party.

For many of the studies, SCHARP uses Medidata Rave for data collection and management, which is 21 CFR Part 11 compliant. If a study has a survey component, and specifically needs audio computer-assisted self-interviews, SCHARP uses REDCap Cloud, which is also 21 CFR Part 11 compliant.

For non-registrational studies and studies that will not be part of a submission for regulatory purposes, SCHARP may use systems that are not 21 CFR Part 11 compliant, such as REDCap.

The quality we bring to researchers is established and a recognized value. We leverage our extensive clinical trial experience to tailor the appropriate level of rigor. For instance, studies in our Phase 1 Discovery Medicine portfolio are designed to have lower regulatory overhead compared to a phase 3 study that is intended for regulatory submission to the FDA. This customized approach improves SCHARP’s cost-effectiveness and ability to turn deliverables around on a faster timeline.