Human Research Protection Program Good Clinical Practice Guidance for Investigators Regulatory File Essential Documents

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1 Guidance for s Regulatory File Essential s All principal investigators must maintain a regulatory binder or file system, which contains all study documentation. These records may be reviewed at the time of an audit. s that pertain to all studies may be kept in a separate file (ie; CVs, lab certificates and laboratory normal ranges, member roster, licenses, CITI training certificates) if so a Memo-to File noting their location should be maintained in the relevant section of the Regulatory File. Retain outdated documents and keep in a separate binder. The following is a list of items some of which may be applicable to a particular research project if so each should be maintained within the regulatory binder. Location Form FDA-1572 Form FDA-1571 Agreement /Commitment Brochure Package insert FDA form required for clinical research studies involving an investigational drug or device regulated by the FDA which is the investigator s agreement to perform the study according to applicable federal regulations. (IND) The cover sheet for investigator-sponsored IND/IDE applications as well as the cover sheet for all subsequent correspondence to the FDA concerning the investigator-sponsored IND/IDE such as annual progress reports, safety reports, modifications etc. (IND/IDE) Similar to the 1572, many device trials utilize an agreement committing the to follow the protocol, control device inventory, requirements and supervision of the research team. (IDE) A document which contains a collection of all relevant information known prior to the start-up of a particular clinical trial and includes pre-clinical data such as chemical, pharmaceutical, toxicological; pharmacokinetic and pharmacodynamic data in animals and man; and the results of earlier clinical trials. (IND) If there is no s brochure, include a package insert describing the medication used in the study. IDE trials often do not have an IB and provide only the insert for reference. (IDE) Page 1 of 6 SOP # 1113-B Effective Date 10/01/2010 Supersedes 10/01/2009

2 Guidance for s Regulatory File Essential s Instructions for Use / Handling of the investigation product and trail related materials. Study Protocol / Research Plan, Amendments and Sample Case Report Forms/Data Collection Tools. Informed Consent s Information Given to study subjects Subject Recruitment tools, advertisements, brochures, reimbursement schedules, ect. Study Contract Insurance Statement The document which specifies technical details of an investigational device and instructions for its use. Instructions are often provided with the Package Insert for training, reference and regulatory documentation. (IND/ IDE) The signed protocol/research plan documents and agreement to the protocol and Case Report Forms or Data Collection tools. Each version of the protocol should be dated for clarity and copies maintained in chronological order. The most current version of the approved protocol should be clearly separated from out-dated versions or amendments. (IND/IDE) The original informed consent approved by the (stamped and dated) should be filed if there are modifications to the Informed Consent, the originals should be accurately dated and maintained in chronological order. Careful attention must be given to this process so that subjects are given the correct version of the Informed Consent document when they are enrolled into the study. (IND/IDE) All information provided to study subjects should be submitted to the with the original protocol and filed in the regulatory binder. (IND/IDE) All information/wording used to recruit / inform study subjects should be submitted to the with the original protocol and filed in the regulatory binder. (IND/IDE) A copy of the contract between and clinical site (financial information may be maintained in the regulatory binder or elsewhere, if elsewhere all financial information should be made available for and ICH governed trial audit). (IND/IDE) s that compensation to subjects(s) for trial-related injury will be available (required for all ICH governed studies) (IND/IDE) Page 2 of 6 SOP # 1113-B Effective Date 10/01/2010 Supersedes 10/01/2009

3 Guidance for s Regulatory File Essential s Conflict of Interest (COI) statements for the Principal and s listed on form 1572, 1571 or equivalent. Copy of all s Curriculum Vitae (CV) and a copy of the current medical, nursing or other practioner license. The COI form is maintained in the regulatory binder. An updated COI form may be required at the close of a study. (IND/IDE) s the qualification and eligibility to conduct the trial and/or provide supervision of subjects and study staff. (IND/IDE) Maine Medical Center Institutional Review Board Membership roster. Medical / Laboratory / Technical Procedures and or tests required by the Protocol Certification or Accreditation or Established quality control and or external quality assessment or Other validation Normal Ranges Sample of Label(s) attached to the Investigational Product Shipping Records for Investigational Products and Trial Related Materials (Receipt and Return) Certificate(s) of Analysis of Investigation Product(s) received. Decoding / Instructions for breaking the Blind in Blinded Trials. And Master Randomization list if s that the is constituted in agreement with GCP and confirms that the Principal is not a voting member of the committee. Include Maine Medical Center Federal Wide Assurance number and expiration date. (IND/IDE) s competence of facility to perform required test and supports reliability of the tests. (IND/IDE) s compliance with applicable labeling regulations and appropriateness of instructions provided to study subjects. (IND/IDE) s shipment dates, batch number, method of shipment and allows tracking of investigational product and study related materials, batch numbers, review of shipping conditions and accountability. (IND/IDE) s the identity, purity, strength of investigational product(s) to be used. (IND) Instructions as to how, in the case of an emergency, the identity of the blinded investigational product can be revealed without breaking the blind for the remaining Page 3 of 6 SOP # 1113-B Effective Date 10/01/2010 Supersedes 10/01/2009

4 Guidance for s Regulatory File Essential s applicable. subjects. (IND/IDE) Site Qualification Visit Report or equivalent Site Initiation Visit Report Monitoring Visit confirmation and follow up letters Relevant Communications; between the and sponsor Letters Meeting notes Notes from telephone discussions Newsletters Serious Adverse Events and Significant Protocol Deviations FDA correspondence Correspondence Data Safety Monitoring Board (DSMB) reports Audit Reports s that the site is deemed suitable for the research project by an external sponsor s what trial procedures were reviewed and who was trained at the clinical site. s external sponsor visits and findings from each visit. s agreements of significant discussions regarding trial administration, protocol violations, trial conduct, adverse event reporting between the investigator and sponsor. Copies of all correspondence related to the reporting of adverse events to the and where applicable, the study sponsor or FDA (i.e.; for investigator-sponsored INDs/ IDEs). All documentation pertinent to the adverse event should be filed in the Regulatory Binder as well as in the individual subject s research record. For investigator-sponsored INDs and IDEs (Note per policies, a copy of all investigator IND and IDE correspondence must be submitted to the ) All correspondence with the including, the application, letters of initial approval, amendment (modifications) and status reports such as, annual renewal, study termination, final summary, etc. should be maintained. Correspondence from/with the DSMB may be filed with Adverse Events / Correspondence or individually. All correspondence and reports from oversight/auditing organizations should be Page 4 of 6 SOP # 1113-B Effective Date 10/01/2010 Supersedes 10/01/2009

5 Guidance for s Regulatory File Essential s filed together. Study Logs; Drug / Device Accountability log Monitoring Visit Log Delegation of Responsibility log Site Signature Log Study / Protocol Training Log Screening Log Enrollment Log Adverse Event Log Protocol Deviation Log Subject Identification List Study Logs should be available in the Regulatory Binder for reviews, auditing and monitoring. Logs should be maintained current with the ongoing research. Study sponsors may provide and require the use of certain logs. It is strongly advised that logs are used to summarize and organize a research project. Drug / Device Accountability, Delegation of Responsibility, Study / Protocol Training Log, Site Signature log and a subject ID list are required by IND / IDE studies. Record of Retained Body Fluids / Tissue Samples Study Close Out Monitoring Visit Report or follow up letter Final Report to the announcing study closure Clinical Study Report (If applicable) s the location and identification of retained samples if assays need to be repeated or samples saved for shipping at a later date. Final Monitoring report or follow up letter confirming clinical site completion of study requirements The principal investigator s final report, which should be signed, dated and forwarded to the and, if applicable, to the sponsor and/or the FDA s the results and interpretation of the research study Page 5 of 6 SOP # 1113-B Effective Date 10/01/2010 Supersedes 10/01/2009

6 Guidance for s Regulatory File Essential s The following documents are also considered essential but may be maintained in individual subject binders Signed Informed Consent Forms Completed, signed, dated Case Report Forms (CRF) Source s ation of Data Corrections ing IC is obtained in accordance with GCP, study Protocol and dated prior to study participation. s that the or delegated research staff member confirms the observations recorded as study data s the existence of the subject and substantiates the integrity of the collected trial data, includes original documents related to the trial, medical/surgical history, and medical surgical treatments documentation if indicated by the protocol s all changes / additions or corrections made to the CRF after the initial data was recorded Page 6 of 6 SOP # 1113-B Effective Date 10/01/2010 Supersedes 10/01/2009

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