DATA HANDLING AND RECORD KEEPING 11.1. Case Report Forms/Electronic Data RecordAs used in this protocol, the term CRF should be understood to refer to either a paper form or an electronic data record or both, depending on the data collection method used in this study. A CRF is required and should be completed for each included participant. The completed original CRFs are the sole property of Pfizer and should not be made available in any form to CCI CCI CCI CCI PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 124third parties, except for authorized representatives of Pfizer or appropriate regulatory authorities, without written permission from Pfizer. The investiga tor shall ensure that the CRFs are securel y stored at the study site in [encry pted electronic and/or paper] form and will be [password protected or secured in a locked room] to prevent access by unauthorized third parties. The investigator has ultimate res ponsibility for the collection and reporting of all clinical, safet y, and laboratory data entered on the CRFs and any other data collection forms (source documents) and ensuring that they are accurate, authentic/original, attributable, complete, consistent , legible, timely (contemporaneous), enduring, and available when required. The CRFs must be signed b y the investigator or b y an authorized staff member to attest that the data contained on the CRFs are true. An y corrections to entries made in the CRFs o r source documents must be dated, initialed, and explained (if necessary) and should not obscure the original entry . In most cases, the source documents are the hospital or the ph ysician’s chart. I n these cases, data collected on the CRFs must match the data in those charts. In some cases, the CRF may also serve as the source document. In these cases, a document should be available at the investigator site and at Pfizer that clearl y identifies those data that will be recorded on the CRF, and for which the CRF will stand as the source document. 11.2. Record Retention To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the investigator agrees to keep records, including the identity of all participating participants (sufficient i nformation to link records, eg, CRFs and hospital records), all original signed informed consent documents, copies of all CRFs, safet y reporting forms, source documents, and detailed records of treatment disposition, and adequate documentation of relevant correspondence (eg, letters, meeting minutes, and telephone call reports). The records should be retained b y the investigator according to ICH guidelines, according to local regulations, or as specified in the clinical study agreement (CSA), whichever is longer. The investigator must ensure that the records continue to be stored securel y for so long as they are retained. If the investigator becomes unable for an y reason to continue to retain study records for the required period (eg, retirement, relocatio n), Pfizer should be prospectivel y notified. The study records must be transferred to a designee acceptable to Pfizer, such as another investigator, another institution, or to an independent third part y arranged by Pfizer. Investigator records must be ke pt for a minimum of 15 years after completion or discontinuation of the study or for longer if required by applicable local regulations. The investigator must obtain Pfizer’s written permission before disposing of an y records, even if retention requirements have been met. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 12512.ETHICS 12.1. Institutional Review Board/Ethics Committee It is the responsibility of the investigator to have prospective approval of the study protocol, protocol amendments, informed consent documents, and other relevant documents, eg, recrui tment advertisements, if applicable, from the I RB/EC. All correspondence with the IRB/EC should be retained in the investigator file. Copies of I RB/EC approvals should be forwarded to Pfizer. The only circumstance in which an amendment may be initiated p rior to IRB/EC approval is where the change is necessary to eliminate apparent immediate hazards to the participants. In that event, the investigator must notify the IRB/EC and Pfizer in writing immediately after the implementation. 12.2. Ethical Conduct of the Study The study will be conducted in accordance with the protocol, legal and regulatory requirements and the general principles set forth in the I nternational Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organiza tions of Medical Sciences 2002), ICH Guideline for Good Clinical Practice, and the Declaration of Helsinki. 12.3. Participant Information and Consent All parties will comply with all applicable laws, including laws regarding the implementation of organizational and technical measures to ensure protection of participant personal data. Such measures will include omitting participant names or other directl y identifiable data in any reports, publications, or other disclosures, except where required by applicable la w. The personal data will be stored at the study site in [encry pted electronic and/or paper] form and will be [password protected or secured in a locked room] to ensure that only authorized study staff have access. The study site will implement appropriate technical and organizational measures to ensure that the personal data can be recovered in the event of disaster. In the event of a potential personal data breach, the study site shall be responsible for determining whether a personal data breach has in fact occurred and, if so, providing breach notifications as required by law. To protect the rights and freedoms of natural persons with regard to the processing of personal data, when study data are compiled for transfer to Pfizer and other authorized parties, participant names will be removed and will be replaced by a single, specific, numerical code, based on a numbering s ystem defined by Pfizer. All other identifiable data transferred to Pfizer or other authorized parties will be identified by this sin gle, subject -specific code. The investigator site will maintain a confidential list of participants who participated in the study , linking each participant’s numerical code to his or her actual identity . In case of data transfer, Pfizer will maintain hig h standards of confidentiality and protection of participants’ personal data consistent with the Clinical Study Agreement and applicable privacy laws. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 126The informed consent documents and an y participant recruitment materials must be in compliance with ICH G CP, local regulatory requirements, and legal requirements, including applicable privacy laws. The informed consent documents used during the informed consent process and any participant recruitment materials must be reviewed and approved b y Pfizer, approve d by the IRB/EC before use, and available for inspection. The investigator must ensure that each study participant or his or her legally acceptable representative is fully informed about the nature and objectives of the study , the sharing of data relating to the study and possible risks associated with participation, including the risks associated with the processing of the participant’s personal data. The investigator further must ensure that each study participant[, or his or her legall y acceptable repre sentative, or parent(s) or legal guardian if a minor,] is fully informed about his or her right to access and correct his or her personal data and to withdraw consent for the processing of his or her personal data. Whenever consent is obtained from a part icipant’s legall y acceptable representative, the participant’s assent (affirmative agreement) must subsequently be obtained when the participant has the capacity to provide assent, as determined by the IRB/EC. If the investigator determines that a partici pant’s decisional capacity is so limited he or she cannot reasonabl y be consulted, then, as permitted b y the IRB/EC and consistent with local regulatory and legal requirements, the participant’s assent may be waived with source documentation of the reason assent was not obtained. If the stud y participant does not provide his or her own consent, the source documents must record wh y the participant did not provide consent (eg, minor, decisionally impaired adult), how the investigator determined that the pers on signing the consent was the participant’s legall y acceptable representative, the consent signer’s relationship to the study participant (eg, parent, spouse), and that the participant’s assent was obtained or waived. If assent is obtained verball y, it must be documented in the source documents. The investigator, or a person designated b y the investigator, will obtain written informed consent from each participant or the participant’s legally acceptable representative before any study -specific activity isperformed unless a waiver of informed consent has been granted b y an IRB/EC. The investigator will retain the original of each participant’s signed consent document. 12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable regulatory authorit y in any area of the world, or if the investigator is aware of an y new information that might influence the evaluation of the benefits and risks of the invest igational product, Pfizer should be informed immediately. In addition, the investigator will inform Pfizer immediately of any urgent safet y measures taken b y the investigator to protect the study participants against an y immediate hazard, and PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 127of an y serious breaches of this protocol or of ICH GCP that the investigator becomes aware of. 13.DEFINITION OF END OF TRIAL 13.1.