Version 11, JAN2017. Regulatory Document Approval Parameters for WebDCU TM POINT. People Document Collection REGULATORY REQUIREMENTS

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1 Regulatory Approval Parameters for WebDCU TM Collection Person Role CV Study Drug Recipient, Secondary SC within document 5 yrs. from effective Required for all site personnel who are directly involved in the study. must have a. Signature is not required. Provide in a PDF attachment. HIPAA HSP Secondary SC, Data Entry, Administrators Secondary SC, Data Entry, Administrators ) ) Site-specific Site-Specific Please follow the local institutional policies for completion and ongoing maintenance of these s. If your institution requires re- and provides an for the, enter this into WebDCU TM and you will receive a notification as that nears. Please provide the corresponding HIPAA for each study team member in a pdf attachment. Please follow the local institutional policies for completion and ongoing maintenance of these s. If your institution requires re- and provides an for the, enter this into WebDCU TM and you will receive a notification as that nears.. Please provide the corresponding HSP for each study team member in a pdf attachment. Medical License Primary Study Drug Recipient, Secondary SC license was issued. If is not provided, use of upload license Upload a copy of the current license into WebDCU TM. Copies of online verifications are valid, unless a disclaimer is noted on the license. Provide in a PDF attachment. Protocol P.I., Primary SC Credit will be given to those who have the. Once, a certificate will be provided; please provide in a PDF attachment in WebDCU TM. Enrollment Data P.I., Primary SC Data Entry Credit will be given to those who have the. Once, a certificate will be provided; please provide in a PDF attachment in WebDCU TM. Provide Data Certificate in a PDF file format in WebDCU TM for anyone assigned CRF completion or Data query resolution responsibility. WebDCU TM data entry access cannot be activated until the certificate is uploaded.. Version 11, JA2017

2 Person Role Regulatory Database Site Pharmacy Data IHSS Maintain Regulatory s Primary Study Drug/Device Recipient anyone Provide Regulatory Database Certificate in a PDF file format in WebDCU TM for anyone assigned responsibility for maintaining regulatory documents.webdcu TM regulatory document access cannot be activated until the certificate is uploaded. Provide Pharmacy Data Certificate in a PDF file format in WebDCU TM WebDCU TM pharmacy accounts can not be activated until the Site Pharmacy Data is uploaded. is required for Investigators and Study Coordinators who will be the IHSS assessment with subjects. Once, a certificate will be provided; please provide in a PDF attachment in WebDCU TM. Physician Information form P.I Good Clinical Practice Primary SC, Secondary SC, and others doing Data Collection/Entry form or 3 years from effective, whichever is earlier Required for CRC sites. For ETT site-please waive. A new ational Institutes of Health (IH) policy (OT-OD ) requires investigators, study coordinator, and data managers involved in the conduct, oversight, or management of IH-funded trials be trained in GCP. This requirement is in addition to (and does not replace) the basic required human subjects (e.g. CITI human subject s modules). The policy notes that must be refreshed every 3 years. Follow your institutional policy for CGP. Provide in a PDF attachment. ABCD2 Secondary SC/anyone is required for Investigators and Study Coordinators who will be the ABCD2 assessment with subjects. Once, a certificate will be provided; please provide in a PDF attachment in WebDCU TM. Sample Handling and Shipping mrs Study team personnel* Primary SC/anyone was granted Complete required based on institutional requirements for drawing, preparing, storing, and shipping blood samples. Upload in a pdf attachment in WebDCU. *All study team members performing this responsibility must complete this is required for Investigators and Study Coordinators who will be the mrs assessment with subjects. Once, a certificate will be provided; please provide in a PDF attachment in WebDCU TM. Version 11, JA2017

3 Collection dd/mmm/y y IRB FWA approval, if a is not provided, use of upload into WebDCU Each Hub must provide documentation of an IRB Federalwide Assurance (FWA). Upload a copy of the FWA to WebDCU TM. The Federalwide Assurance (FWA) is how institutions attest that they will comply with federal rules governing the conduct of clinical trials. Full Study IRB Application Submittal* (Protocol Version) of submission on document ation that the full application has been submitted to the IRB for all participating Hubs/ s. This application should include results from the final Protocol, Package Insert for Clopidogrel, FDA ID Exemption Letter, Informed Consent Forms, and the DSMB plan (if applicable). This must be documented by uploading the confirmation of submittal and the full application into WebDCU. *ote only the initial full application must be uploaded into WebDCU. For subsequent submissions (i.e. continuing renewal), only the IRB approval with documentation listing all documents reviewed and approved must be uploaded. Version 11, JA2017

4 Effectiv e dd/mmm/y Protocol IRB Approval approval Provide the IRB approval letter clearly documenting the protocol version and approval. Continuing Renewals are posted here. IRB Approved Informed Consent Form(s) approval Prior to submitting to your IRB, your Informed Consent Forms must be reviewed and approved by the CCC Once the CCC review is, please submit to your IRB for approval. In WebDCU TM, provide written documentation of the IRB approval of the Informed Consent Forms with clear documentation of the IRB approval. Provide in a PDF attachment explicitly showing IRB approval. Delegation of Authority Log Use uploaded in WebDCU Leave Blank This document type will be available and used for sites that have a local(institutional or country) requirement to maintain a paper DOA log. Hub PI Attestation of Re *required for ETT sites Use Signature Leave Blank Signed by Hub PI once re- is. Study Drug Destruction Policy approval Leave Blank Provide institutional/pharmacy SOP that covers local guidelines for drug destruction on site. Version 11, JA2017

5 CLIA CLIA is required. Upload copies of the certificate to WebDCU TM. If a current certificate is not yet available, a note from the lab can be uploaded in WebDCU until the official document is available. HSP and HIPPA policies approval Required for ETT sites. For CRC sites-please waive. Provide HSP and HIPAA / policies for research as required at your local research administration office or site IRB policies. Combine HSP and HIPAA policy into 1 single PDF and upload. OTE; We need to see the interval/duration of /re(e.g. HSP required every 3 years, etc.) Office of Research Integrity (ORI) Assurance *required for CRC sites l IRB Study Modification otifications IRB Closeout otification IRB Closeout Acknowledg ment approval es use es use es use., if applicable Any site who has previously received a grant through IH will already have established an initial assurance. If you have not established this assurance, or if you are unsure of your status, please contact Robin Parker at Robin.Parker@hhs.gov Written notification to the IRB of changes to study team; study materials; IRB acknowledgement of protocol deviations; or any document previously approved by a site s IRB (OTE IRB approval letters and consent forms are still posted to their respective entries.) Leave Blank Written notification to the IRB of the study s closure at hub/spoke. Leave Blank Written documentation of the IRB acknowledgment or approval of study s closure at hub/spoke. Version 11, Upd JA2017