Modification of the Protocol. Any changes in this research activity, except those necessary to remove an apparent immediate hazard to the patient, require a protocol amendment signed by the principal study investigator and research institution investigator, and approved by the IRB (or equivalent) before implementation.
Modification of the Protocol. Any changes in this research activity, except those necessary to remove an apparent immediate hazard to the subject, must be reviewed and approved by SIGA or designee. Amendments to the protocol must be submitted in writing to the IRB for approval before subjects are enrolled into an amended protocol.
Modification of the Protocol. Any changes that arise after the approval of the protocol must be documented as protocol amendments. The FDA or other applicable regulatory agencies must be notified of protocol amendments. The changes will become effective only after approval of the Sponsor, the investigator, the IRB/EC, and where necessary, the applicable regulatory agency. In cases when the protocol is modified to enhance patient safety, changes may be implemented and the amendment must be immediately submitted to the IRB/EC. The investigator is responsible for informing the IRB/EC of all problems involving risks to patients according to national legislation. In case of urgent safety measures, the Sponsor will immediately notify the investigators and relevant regulatory agencies, including FDA in accord with 21 CFR 312.32.
Modification of the Protocol. Any modification of this Protocol must be made in writing and previously approved by the competent corporate bodies of each of the Parties, with the abstention, if appropriate, of the members of those corporate bodies of each of the Parties that represent the other Party, or that may have been appointed at the proposal of the other Party.
Modification of the Protocol. On the basis of the Phase 2 primary efficacy analyses, the Sponsor may reduce the Phase 3 sample size and/or change the percentage of patients with macroalbuminuria (ACR > 300 mg/g) eligible to enroll in the study. These changes will be documented in a note-to-file to the investigators/IRBs/ECs (as appropriate) and will not require a protocol amendment. Any other changes that arise after the approval of the protocol must be documented as protocol amendments. The FDA or other applicable regulatory agencies must be notified of protocol amendments. The changes will become effective only after approval of the Sponsor, the investigator, the IRB/EC, and where necessary, the applicable regulatory agency. In cases when the protocol is modified to enhance patient safety, changes may be implemented and the amendment must be immediately submitted to the IRB/EC. The investigator is responsible for informing the IRB/EC of all problems involving risks to patients according to national legislation. In case of urgent safety measures, the Sponsor will immediately notify the investigators and relevant regulatory agencies, including FDA in accord with 21 CFR 312.32.
