4.1. Accurate: The information is a true reflection of the original observation.

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1 SOP #: DOC-101 Page: 1 of 7 Effective Date: 1. POLICY STATEMENT: The Principal Investigator and research team members are required to prepare and maintain adequate and accurate case histories designed to record all observations and other data pertinent to the investigation on each subject. Source documents include all original records from which case report forms (CRFs) and data collection forms are completed and all medical records and research charts used to document source data. 2. BACKGROUND: None 3. RESPONSIBLE PERSONNEL: 3.1. Overall Principal Investigator (PI) 3.2. Site Responsible Investigator 3.3. Subinvestigator 3.4. Research Nurse 3.5. Study Coordinator 4. DEFINITIONS: 4.1. Accurate: The information is a true reflection of the original observation Case History: A record of all observations and other data pertinent to the research on each individual enrolled in a research Case Report Form (CRF): A document designed to record all of the protocolrequired information to be reported to the sponsor on each subject. Case report form information is transcribed from source data recorded on source documents Legible: All source data must be clear, readable, and interpretable Original: The first recording of the observation. Effective Date: 0

2 SOP #: DOC-101 Page: 2 of 7 Effective Date: 4.6. Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a study necessary for the reconstruction and evaluation of the study. Source data are contained in source documents Source Document: Original documents, data, and records Subject: Under the FDA regulations, an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. For non-fda regulated research, a subject is a living individual about whom an investigator obtains: 1) data through intervention or interaction with the individual; or 2) identifiable private information. 5. POLICY: 5.1. The Overall PI and research team are responsible for ensuring source documentation is sufficient to support subject participation in the research. Source documentation must enable CRF entries to be verifiable. The Overall PI may delegate the task of source documentation to qualified research team members after ensuring their experience and training. Final determination of subject eligibility must be signed off by a physician investigator before a subject is registered on a trial Rules for Source Entry: Recorded observations that are used as source documents must be signed or initialed and dated Unless otherwise stipulated by the Institutional Review Board (IRB), source documents will have clear subject identifiers (i.e., screen number, randomization number, initials) to track the document to the participating subject All source documents are dated by the research team member making the source entry The Case Report Form (CRF/eCRF) must only be a collection of transcribed source data (unless otherwise defined in the protocol). The source documents must capture all information required in the CRFs, (e.g., physical exam requirements, all adverse event parameters, etc.). Effective Date: 0

3 SOP #: DOC-101 Page: 3 of 7 Effective Date: The CASE REPORT FORM cannot be used as a source document unless the sponsor specifically identifies the forms in the protocol for direct entry prior to study start-up Any change or correction to a source document or paper CRF must be dated, initialed, explained (as necessary), and must not obscure the original entry. Amended versions of notes in the Medical Record System are acceptable If an Overall PI uses Satellite sites or the Dana-Farber/Partners Cancer Care (DF/PCC) Network Affiliates, the satellite and affiliate facilities must follow the same source document and record-keeping practices as the main location Specific Requirements for Medical Records and Research Charts: The medical records and research charts are the only chronological subject records to remain long after the research is completed. These records and the information captured are potentially important to the subject s future well-being, care, and treatment. The following is a list of requirements for entries in the medical record and/or the research chart: When the research relates to clinical activity, a record of the subject s participation in the research; abbreviated description of the purpose and nature of the trial, including active control and/or placebo if known, and dates of participation are recorded in the medical record A record of the subject consenting to research participation. For research related to clinical activity, the consenting process is recorded in the medical record. Otherwise the consenting process is recorded in the research chart. A description of the consenting process includes the date(s) of consent and states that the subject (or legally authorized representative) has received an explanation of the content of the consent. If witnesses or others were present this is noted. If any new safety information is presented to the subject (or legally authorized representative) that may affect participation and is not documented in the informed consent document, the verbal consent must be documented. Effective Date: 0

4 SOP #: DOC-101 Page: 4 of 7 Effective Date: When applicable, note that the subject (or legally authorized representative) had an opportunity to ask questions about the research and received a signed and dated copy of the informed consent document. The signed informed consent document is retained in the research chart All adverse event parameters must be captured in the source notes. It is the responsibility of the designated research team member to determine the severity and duration of the event, and assess the relationship of the event to the investigational drug(s)/device(s) or research intervention(s) A record of each visit and synopsis of progress in addition to all the information required at that visit is required to support all data in the CRFs (including Quality of Life Questionnaires, Diaries, etc) The records including per visit progress notes, concomitant medications, vitals, etc. will be completed in a timely manner The records need to clearly identify who made the observations or made decisions regarding the subject s care All deviations, exemptions, or waivers (e.g., from inclusion/exclusion criteria) must be recorded in the subject s records and have written prospective approval from the sponsor and the IRB prior to the subject s participation (or continued participation) in the protocol Original records such as laboratory, radiology, or cardiology reports (i.e. EKGs) must be reviewed and the review must be documented. For laboratory reports and EKGs, abnormal or out of range values must be assessed for clinical significance Provide a summary statement when the subject has completed the research stating the condition and disposition of the subject at that point. Effective Date: 0

5 SOP #: DOC-101 Page: 5 of 7 Effective Date: 5.4. Case Report Forms Used as Source Documents: The CRF/eCRF can only be used as a source when specifically identified by the sponsor in the IRB approved protocol. When the CRF/eCRF is used as a source document, the following requirements must be followed: The CRF pages are treated in the same fashion as all other source documents, maintaining all the data quality attributes CRF pages routinely used as source documents are medical evaluations, patient quality of life questionnaires (QOL), or subject self-evaluations such as diaries, rating scales, and visual analogue scales. The person completing the CRF (research team members, rater, or subject) signs or initials and dates the actual CRF page. Assessments, such as QOLs, that are required to be confidential must not be signed and dated by the subject If the sponsor does not provide a signature line, the diary must still be signed or initialed and dated by the person completing the diary, preferably the study subject The person making the observation (whether it is a subject or a research team member) signs (or initials if stated on the form) and dates the entry. If no place is designated for date and signature or initials on the CRF, it still needs to be signed or initialed and dated at the appropriate time point If the CRF is a three-part document, extra care should go into writing down observations to ensure that a legible and readable copy remains at the site. Adequate pressure must be placed on the document to produce a clear, legible pink (sponsors may have a different color that remains with the investigator) third copy. The pink copy is to be retained at the site Source Preparation: The Overall PI with the assistance of appropriate research team members will develop study-specific source document templates to ensure thorough, prospective data collection if not covered in a routine charted source Effective Date: 0

6 SOP #: DOC-101 Page: 6 of 7 Effective Date: document. Sponsor generated data collection tools may be used for source documentation, if specified in the protocol and not in conflict with local policies and procedures. Progress notes will cover all subject interactions and observations, the subject s progress on the research, and the subject s exposure to and experience with the investigational drug(s)/device(s) or intervention(s) The Overall PI and a designated research team member will review protocol requirements and data collection procedures with the other research team members. The designated research team member will work closely with the other members of the research team to ensure protocol compliance and appropriate documentation of protocol-required data points by training and review of documentation The research team will ensure that all study-related source documents are labeled with appropriate subject identification. All documentation pertaining to clinical assessments and medical evaluations must be signed and dated by an appropriate member of the research team The Overall PI and research team members are permitted to make late entries or addendums to medical records when new information is provided or clarifications are necessary. This information may best be explained in a progress note filed with the corrected or updated information. Entries are corrected by the person that made that entry and the date the correction was made needs to be entered. To correct information written on paper, a single line is made through the incorrect entry. No prior entry is ever obscured. No correction fluid or tape is used. Personnel not listed on the Delegation of Authority log can not write on CRFs or source documents The research team will ensure that personal identifying information on copies of source documents to be submitted to the sponsor or IRB in support of CRF entries is blackened out or obliterated except for the subject's initials and research identification number in order to protect subject confidentiality If the sponsor is using a CRF remote data capture system, the research team will keep source documentation in support of electronic entries in a research chart for the subject. Effective Date: 0

7 SOP #: DOC-101 Page: 7 of 7 Effective Date: 6. APPLICABLE REGULATIONS & GUIDELINES: 21 CFR 50 Protection of Human Research Subjects 21 CFR 54 Financial Disclosure by Clinical Investigators 21 CFR 56 Institutional Review Boards 21 CFR Investigational New Drugs Drugs for Human Use 21 CFR 812 Investigational Device Exemptions 45 CFR 46 Protection of Human Subjects FDA Industry Guidelines and Information Sheets FDA Compliance Policy Guidance Programs: , , and RELATED REFERENCES: International Conference on Harmonisation E6 8. RELATED FORMS & TOOLS: DF/HCC Guidance on Source Documents DF/HCC Guidance on Good Study Documentation Practices Effective Date: 0

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