Clinical Monitoring. The CTSN DCC will be responsible for Clinical Research Site monitoring and quality assurance of all data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with current Good Clinical Practice Guidelines The CTSN DCC will communicate any clinically significant findings from clinical monitors to the NHLBI and Company in a timely manner.
Clinical Monitoring. Medpace operates in North America with a primarily centralized monitoring team of over 140 CRAs to promote greater standardization, cohesiveness, support, and stability. Each of the Medpace CRAs assigned to this project have monitoring experience and strong clinical backgrounds. Clinical Safety The Clinical Safety will be managed by VIVUS or its designee. VIVUS Clinical Leader to be involved with casualty assignment for all Serious Adverse Events (SAEs).
Clinical Monitoring. Monitoring will be conducted by the Institution, NIH or their designee in compliance with applicable provisions of the FDA Good Clinical Practices. The Institution will communicate any clinically significant findings from clinical monitors to the Company in a timely manner.
Clinical Monitoring. Oramed Medpace N/A Item Description X Clinical Research Associates (CRAs) 3 CRAs X Qualification visits 1 visit, 4 hrs. on-site; Cost of $2,347 shall be charged for each additional visit X Monitoring plan Ongoing updates Includes monthly meetings X Site initiation visits 10 visits, 4 hrs. on-site; Cost of $2,347 shall be charged for each additional visit X Routine monitoring visits (RMVs) 40 visits X Frequency of RMVs On average, every 5-6 weeks, as needed X Estimated on-site time 16 hours X Close-out visits Assumed combined with final RMV X In-house monitoring coordination Medpace CRA contact sites to discuss project-specific issues; records maintained in ClinTrak
Clinical Monitoring. As this study is not a clinical trial, no clinical regulatory organisation will be involved in monitoring. We will comply to any monitoring requirements from the EDCTP.
Clinical Monitoring. The NIAID will be responsible for Clinical Research Site monitoring and quality assurance of data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with applicable provisions of the current ICH E6. The NIAID will communicate any clinically significant protocol violation findings from clinical monitors to the Company in a timely manner.” [COMMENT: If the Company will be performing quality audit visits add the following to 3.2: “The Company may perform quality audit visits and will coordinate those visits with [Insert appropriate Division, Office, NIAID] only if such audits are allowed and feasible under Sections 8 and 11.”] Option 2 for 3.2
Clinical Monitoring. 3.2.1 The Company will be responsible for Clinical Research Site monitoring and quality assurance of all data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with the current ICH E6. A clinical monitoring plan and site visit plan must be developed by the Company and submitted for review and comment to NIAID prior to initiation of the Clinical Trial. The Company must coordinate its clinical monitoring with NIAID. The Company will communicate significant Protocol violations or reports of insufficiencies from clinical monitors to NIAID in a timely manner.
Clinical Monitoring. The Company will be responsible for Clinical Research Site monitoring and quality assurance of all data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with the current ICH E6. A clinical monitoring plan and site visit plan must be developed by the Company and submitted for review and comment to NIAID prior to initiation of the Clinical Trial. The Company must coordinate its clinical monitoring with NIAID. The Company will communicate significant Protocol violations or reports of insufficiencies from clinical monitors to NIAID in a timely manner. NIAID may, during the term of this Agreement, conduct quality assurance audits of the clinical monitoring performed by the Company for this Clinical Trial. XXXXX must give the Company ten (10) calendar days’ notice in writing of any audit to be conducted under this Agreement. The NIAID audit will be at the cost of NIAID.
Clinical Monitoring. (a) MIMC will assign a qualified Monitor to each Investigator Site. At the initiation visit, the Monitor will determine whether such site is fully equipped with the correct supply of investigational drugs, CRFs and other medical supplies and all forms necessary for proper implementation of the Protocol. At such time, the Monitor will discuss the Protocol with the Investigator, any on-site coordinator, and other members of Investigator's staff; will collect all necessary documentation for implementation of the study; and will provide such persons with a detailed outline of the procedures to be followed in executing the Protocol and conducting the Study. The Sponsor may choose to attend any such initiation visit as long as notice of such intent is provided to MIMC within one (1) week prior to the scheduled visit.
