Reporting Instructions. All SAEs and other events requiring expedited reporting must be reported using B-001 SAE CRF and submitted to DSSM within 24 hours of the study site personnel's initial notification of the event. • When reporting potential Hy's Law cases, the SAE CRF should include the following: - Seriousness Criteria = Important Medical Event - Assessment/Narrative: Include the term “Potential Hy’s Law case” in the narrative; the text should also detail what additional study results are available at the time of reporting and what other studies are planned or results pending to further investigate alternative causes of the abnormal ALT/AST or bilirubin that triggered the report. The timing of planned patient follow-up should also be noted. See Section 8.4. • NSABP will forward expedited report forms that meet reporting requirements concurrently to the FDA and to Merck and Antigen Express pharmacovigilance divisions with the causality assessment. • Investigators are responsible for reporting AEs that meet specific criteria to their local IRBs.
Reporting Instructions. The HR Department must receive this written notification within 5 business days for minor driving violations. All other notifications listed below must be received by the HR Department on the staff member’s next scheduled work day. You may fax this form to the HR confidential fax line at 000-000-0000. The HR Department does not require an original copy of this form; fax or photocopies are acceptable. Keep a copy of this form for your records.
Reporting Instructions. The consultant will report to the eu4Moldova: startup city Cahul project deputy director or her project deputies/designee, who will be responsible for supervising the consultants’ performance.
Reporting Instructions. The Contractor shall ensure that all interpreters are at the specific event location 15 minutes before scheduled time of event, every day dressed in appropriate professional appearance (for example, slacks and polo or collared shirt).
Reporting Instructions. You will need to use Fund ID "K" on the Part IV of the DSS 1571. Costs will be tracked in the Services Section on the XS335 and XS337 under application code 345 with the description "ILP 100% Aftercare". Reimbursement is 100% Federal funds. (Note: Application Code 345 will not appear on the XS325.)
Reporting Instructions. Those debt securities and deposits with a maturity of less than 3 months must be shown within ‘Cash and Cash Equivalents’ Under ‘Deposits and Debt Securities’ in the Reporting Pack.
Reporting Instructions. Throughout the performance of the project, it is important that you mark Protected Data/Limited Rights Data as described in Appendix A. It is equally important that you not submit Protected Personally Identifiable Information (Protected PII)
Reporting Instructions. All SAEs and other events requiring expedited reporting must be reported using FB-12 SAE eCRF and source documentation submitted to DSSM within 24 hours of the study site personnel's initial notification of the event (see Information Resources). - NSABP will forward expedited report forms and their supporting documentation for SAEs that meet reporting requirements to the FDA and also to Genentech, a Member of the Roche Group. - Investigators are responsible for reporting AEs that meet specific criteria to their local IRBs.
