It is also stated in the Research Authorization that their research data may be shared with others at the time of study publication . 17.3 Serious Adverse Event (SAE) Reporting An adverse event is considered serious if it results in ANY of the following outcomes: • Death • A life-threatening adverse event • An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions • A congenital anomaly/birth defect • Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition • List any additional events that require SAE reporting (pregnancy, AEs of special interest (AESI), secondary malignancies, etc.) Note: Hospital admission for a planned procedure/disease treatment is not considered an SAE. SAE reporting is required as soon as the participant starts investigational treatment/intervention. SAE reporting is required for 30 days after the participant’s last investigational treatment/intervention. Any event that occurs after the 30-day period that is unexpected and at least possibly related to protocol treatment must be reported. Please note: Any SAE that occurs prior to the start of investigational treatment/intervention and is related to a screening test or procedure (e.g., a screening biopsy) must be reported. All SAEs must be submitted in PIMS. If an SAE requires submission to the HRPP Office per IRB SOP RR-408 ‘Reporting of Serious Adverse Events ,’ the SAE report must be submitted within 5 calendar days of the event. All other SAEs must be submitted within 30 calendar days of the event. The report should contain the following information: • The date the adverse event occurred • The adverse event • The grade of the event • Relationship of the adverse event to the treatment(s) Memorial Sloan Kettering Cancer Center IRB Number: 17- 358 A(7) Approval date: 25 -Feb-2022 Page 48 of 51 • If the AE was expected • Detailed text that includes the following o An explanation of how the AE was handled o A description of the participant’s condition o Indication if the participant remains on the study • If an amendment will need to be made to the protocol and/or consent form • If the SAE is an Unanticipated Problem For IND/IDE protocols: The SAE report should be completed as per above instructions. If appropriate, the report will be forwarded to the FDA by the IND Office. For multicenter trials where MSK is the data coordinating center, please refer to the MSK Multicenter Trial Addendum. All required SAE reporting to the funders and/or drug suppliers will be completed by MSK only. 17.3.1 SAE Reporting to Study Sponsor / Drug Supplier The following reportable events must be submitted to Pfizer within 24 hours (or immediately for death or life-threatening events) using the provided Investigator -Initiated Research Serious Adverse Event Form (IIR SAE) with the Pfizer Reportable Events Fax Cover Sheet with each SAE submission. • Serious Adverse Events • Exposure during Pregnancy or Breastfeeding (even if not associated with an adverse event) • Occupational exposure (even if not associated with an adverse event) • Potential drug- induced liver injury (Hy‟s Law cases): These events are considered important medical events and should be reported as S AE s . Detailed guidance on the safety reporting is provided in the Safety Reporting Reference Manual. Contact information for submission of reportable events to Pfizer: • Fax: Pfizer U.S. Clinical Trial Department, Fax 1-866-997-8322. or • E-mail: USA.AEReporting@pfizer.com , specifying: o PROTOCOL: o SUBJECT: o SITE/PI: o SAE/ONSET: 18.1 INFORMED CONSENT PROCEDURES Before protocol -specified procedures are carried out, consenting professionals will explain full details of the protocol and study procedures as well as the risks involved to participants prior to their inclusion in the study. Participants will also be informed that they are free to withdraw from the study at any time. All participants must sign an IRB/PB- approved consent form indicating their consent to participate. This consent form meets the requirements of the Code of Federal Regulations and the Institutional Review Board/Privacy Board of this Center. The consent form will include the following: 1. The nature and objectives, potential risks and benefits of the intended s tudy. 2. The length of study and the likely follow -up r equir ed. Memorial Sloan Kettering Cancer Center IRB Number: 17- 358 A(7) Approval date: 25 -Feb-2022 Page 49 of 51 3. Alternatives to the proposed study. (This will include available standard and investigational therapies. In addition, patients will be offered an option of supportive care for therapeutic studies.) 4. The name of the investigator(s) responsible for the pr otoc ol . 5. The right of the participant to accept or refuse study interventions/interactions and to withdraw from participation at any time. Before any protocol -specific procedures can be carried out, the consenting professional will fully explain the aspects of patient privacy concerning research specific information. In addition to signing the IRB Informed Consent, all patients must agree to the Research Authorization component of the informed consent form. Both the participant and the consenting professional will sign the consent form. The participant must receive a copy of the signed informed consent f o r m . Memorial Sloan Kettering Cancer Center IRB Number: 17- 358 A(7) Approval date: 25 -Feb-2022 Page 50 of 51 Version: 2/26/16 19.0 REFERENCES 1. Golden, E.B., et al., Local radiotherapy and granulocyte -macrophage colony -stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof -of- principle trial. The Lancet Oncology, 2015.