Interim Monitoring Visits. At each interim monitoring visit the ICON monitor will confirm site adherence to the protocol, confirm fulfillment of FDA requirements, verify CRFs against source documents, assure proper CRF completion, verify informed consents, ensure proper SAE reporting, record retention, adequacy of study supplies, proper study product storage and accountability. Closeout Visits (Including Un-Blinded) • At each site closeout visit the ICON monitor will perform complete study product reconciliation, verify that all CRFs are completed and monitored, and perform a review of investigator responsibilities (including record retention requirements, verification of investigator files for completeness and accuracy, and completion of the site closure form by the investigator). • After site closeout visit activities have been completed, ICON will send a closeout letter to the site; a record of relevant supplies and all documentation will also be forwarded to Genta or archived in accordance with relevant ICON SOPs. In-House Site Management • The ICON monitor will conduct in-house monitoring activities as needed during the study. • In-house site management activities will include site contact, generation of contact reports, site status tracking, attendance at team meetings, attendance at team training, responding to site questions, maintenance of updated investigator regulatory documents, issue resolution from previous site monitoring visits, responding to data queries, planning next visits (site contact documentation and travel plans), Serious Adverse Event (SAE) reporting and follow up and reconciliation as needed, generation of trip reports, creation of follow up letters documenting trip status, replenishing site supplies (i.e. case report forms, study product), responding to audit findings, assist as needed with mass distribution of information, and maintaining the investigator file. ICON will maintain telephone contact with sites on a regular basis throughout the study. Project Meetings • Regular project meetings will be held involving key team members from Genta and ICON in order to monitor study progress and address and resolve any problems that may be identified.
Interim Monitoring Visits. Aptiv Solutions will conduct initial interim site visit within two weeks after the first patient is enrolled at each site unless otherwise directed by Actinium; subsequent monitoring visits will be scheduled depending on enrollment rate and data quality. The frequency and length of visits will be adjusted as agreed upon by Actinium and Aptiv Solutions. Aptiv Solutions has assumed 12 one day (8 hours on-site) Interim Monitoring Visits per site. The monitoring plan can be written to allow the flexibility of more or fewer visits per site, as agreed upon with Actinium, as site-level enrollment warrants. The data quality will be reviewed after the first subject to identify any issues related to the protocol and retraining will occur, as applicable.
Interim Monitoring Visits. Interim monitoring visits will be conducted at each Clinical Site at a regular frequency according to the study needs during enrollment and follow-up. Each visit can last anywhere from 6-8 hours and will be dependent upon the Clinical Site’s patient enrollment rates and the complexity of the source document verification. Between monitoring visits, the Clinical Research Associates (CRAs) will contact Clinical Sites to assess enrollment activity, answer study related questions, resolve queries and assist with any other issues regarding study conduct. This contact will occur every one to two weeks. If additional onsite interim monitoring visits are needed, InspireMD will be consulted for approval. Interim Site Visit Reports will be submitted to InspireMD following each visit. At the Interim Monitoring Visits the CRA will: · Assess enrollment and continuing protocol adherence; · Review all relevant source documents, in accordance with the Monitoring Plan; · Report any previously unreported SAEs to HCRI and InspireMD; · Investigate and resolve any outstanding queries; · Ensure that the investigational product is accounted for and that records are accurate; · Conduct a continuing review of the Investigator study file for regulatory adherence and to ensure that GCP/ICH guidelines are being followed, and · Perform 100% source documentation of the data entered, unless otherwise specified by InspireMD.
Interim Monitoring Visits. STUDY MONITORING VISITS/SITE MANAGEMENT *Confidential treatment requested: Material has been omitted and filed with the Commission. WORK ORDER 1 CUBIST PHARMACEUTICALS, INC. DAP-CAP-00-08 ATTACHMENT I SCOPE OF WORK
