Ethics Review. The final study protocol, including the final version of the ICF, must be approved or given a favorable opinion in writing by an IRB or IEC as appropriate. The Investigator must submit written approval to Sage Therapeutics or designee before he or she can enroll any subject into the study. The Principal Investigator is responsible for informing the IRB or IEC of any amendment to the protocol in accordance with local requirements. In addition, the IRB or IEC must approve all advertising used to recruit subjects for the study. The protocol must be re-approved by the IRB or IEC upon receipt of amendments and annually, as local regulations require. The Principal Investigator is also responsible for providing the IRB with reports of any reportable serious adverse drug reactions from any other study conducted with the investigational product. Sage Therapeutics or designee will provide this information to the Principal Investigator. Progress reports and notifications of serious adverse drug reactions will be provided to the IRB or IEC according to local regulations and guidelines.
Ethics Review. I first submitted a REMAS ethics review in January of 2017 under the guidance of Xxxx Xxxxxx. We determined the process to be minimal risk because:
Ethics Review. The final study protocol, including the final version of the Informed Consent Form, must be given a written and dated approval or favorable opinion by an IRB or IEC as appropriate. The investigator must obtain and document approval before he or she can enroll any participant into the study. The IRB or IEC must supply to the sponsor a list of the IRB/IEC membership and a statement to confirm that the IRB/IEC is organized and operates according to GCP and applicable laws and regulations. The principal investigator is responsible for informing the IRB or IEC of any amendment to the protocol in accordance with local requirements. In addition, the IRB or IEC must approve all advertising used to recruit participants for the study. The protocol must be re-approved by the IRB or IEC upon receipt of amendments and annually, as local regulations require. The principal investigator is also responsible for providing the IRB or IEC with reports of any reportable serious adverse drug reactions from any other study conducted with the investigational product. Sage Therapeutics will provide this information to the principal investigator. Progress reports and notifications of serious adverse drug reactions will be provided to the IRB or IEC according to local regulations and guidelines. In addition, the principal investigator must inform the IRB/IEC and sponsor of any changes significantly affecting the conduct of the trial and/or increasing the risk to participants (eg, violations to the protocol or urgent safety measures taken for participant safety).
Ethics Review. The Agency carries out the ethics pre-screening and the screening of proposals, according to Horizon 2020 Vademecum23. If an ethic assessment is necessary, further to the screening, the Agency will request the Ethics Department of DG RTD to perform it. In exceptional cases, such an assessment may also be carried out at the request of the Commission services or the Agency notably via the Horizon 2020 SEP system. In case of complaints on ethics, the Agency convenes a committee according to the relevant provisions provided in the Horizon 2020 Vademecum.
Ethics Review. The final study protocol, including the final version of the informed consent form, must be approved or given a favorable opinion in writing by an IRB/IEC as appropriate. The Investigator must submit written approval to La Jolla before he or she can enroll any patient into the study. The Investigator is responsible for informing the IRB/IEC of any amendment to the protocol in accordance with local requirements. In addition, the IRB/IEC must approve all advertising used to recruit patients for the study, if applicable. The protocol must be re-approved by the IRB/IEC upon receipt of amendments and annually, as local regulations require. The Investigator is also responsible for providing the IRB with reports of any reportable serious adverse drug reactions from any other study conducted with the investigational product. La Jolla will provide this information to the Investigator. Progress reports and notifications of serious adverse drug reactions will be provided to the IRB/IEC according to local regulations and guidelines.
Ethics Review. The final study protocol and the final version of the ICF, and other study related material, as appropriate, must be approved or given a favorable opinion in writing by an IRB or IEC as appropriate. The Principal Investigator must submit written approval to RIBOMIC (or designee) before study initiation. See Appendix 1 for a list of obligations of Investigators. The Principal Investigator is responsible for informing the IRB or IEC of any amendment to the protocol in accordance with local regulations and guidelines. In addition, the IRB or IEC must approve all advertising used to recruit subjects for the study. The protocol must be re-approved by the IRB or IEC upon receipt of amendments and at least annually. The Principal Investigator is also responsible for providing the IRB or IEC with progress reports and notifications of any reportable SAEs attributable to the investigational product.
