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14 Mar Documentation
Theme/Plugin Docs Bridge LayerSlider Visual Composer ...05 Mar Monitoring Services
Monitoring Services ITHS offers clinical study monitoring to help investigators who are required by FDA or their funding agency to have ongoing independent review of their research records. ITHS monitoring services helps clinical investigators to: Maintain compliance with international, federal, state, local, institutional, and protocol-driven regulatory requirements for clinical research Ensure the accuracy of research data, including source document verification,...05 Mar Auditing and Quality Assurance Review Services
Auditing and Quality Assurance Review Services ITHS offers auditing and quality assurance review services for departments and investigators who are interested in one-time data checks. The goal of these programs is to ensure your study is run efficiently and effectively to produce high-quality data. ITHS Auditing & Quality Assurance Review Services helps departments and individual investigators to: Prepare for inspections...05 Mar Recruitment Resources
Recruitment Resources The purpose of clinical research is to gather data and answer questions that will be used to improve human health. However, slow participant accrual can result in studies closing prior to completion or remaining open past intended completion dates. These accrual challenges can thereby expose participants and volunteers to potential study risks without contributing any new knowledge to...
05 Mar Helpful Links
Helpful Links to Resources We have compiled links to a number of helpful links and resources in this section of our website. Please feel free to contact us if you would like to suggest other materials for us to add. Are you not finding the right facility or resource to meet your research needs? ITHS is pleased to offer a...
06 Mar When are Data and Safety Monitoring Boards (DSMBs) needed?
NIH Guidance on When Data and Safety Monitoring Boards (DSMBs) are Needed The NIH requires a data and safety monitoring board (DSMB) for Phase III clinical investigations (or any multi-site clinical trial) involving interventions that entail potential risk to participants. For phase I and II trials, a DSMB may be appropriate if the studies have multiple clinical sites, are blinded,...