{End sample text for ISM} sample text for NIDCR Medical Monitor} In addition to the PI’s responsibility for oversight, study oversight will be under the direction of the NIDCR Medical Monitor. The PI will submit a report every 6 months to the NIDCR Medical Monitor for review. This report will include data regarding enrollment and retention, unanticipated problems and protocol deviations, disposition of biospecimens, outcome measures, quality management findings and other relevant parameters. If necessary, additional steps may be taken to ensure data integrity and protocol compliance. {End sample text for Medical Monitor}
{End sample text for ISM} sample text for NIDCR Medical Monitor} In addition to the PI’s responsibility for oversight, study oversight will be under the direction of the NIDCR Medical Monitor. The PI will submit a report every 6 months to the NIDCR Medical Monitor for review. This report will include data regarding enrollment and retention, unanticipated problems and protocol deviations, disposition of biospecimens, outcome measures, quality management findings and other relevant parameters. If necessary, additional steps may be taken to ensure data integrity and protocol compliance. {End sample text for Medical Monitor}
clinical-trial-interventional-protocol-template.docx