Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for the following 2 questions Please address following questions: 1. How would you as a Clinical...

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Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for the following 2 questions



Please address following questions:


1. How would you as a Clinical Research Manager ensure that your team's study files and essential documents were properly and correctly managed?


2. What tools and resources might you or your team use to manage regulatory documents?



**Please utilize the following YouTube videos as well as the Attached PDFs, which is requirement of the paper – feel free to utilize other resources if needed but these videos and pdf are part of the requirement**



https://www.youtube.com/watch?v=dwwpr_ynmo8



https://www.youtube.com/watch?v=jQlk7WXno40



https://www.youtube.com/watch?v=27k5i1lqNlQ&t=2s



https://www.youtube.com/watch?v=5bLgd-ln0BY



https://www.youtube.com/watch?v=7miYVoZIemE




PowerPoint Presentation Regulatory Management  Beth Loots, MPH MSW Contents   Good Documentation Practice (GDP), ALCOA-C, and correcting study information Essential regulatory documents  Managing patient files Good Documentation Practice (GDP), ALCOA-C, and Correcting Information What is GDP Documentation should tell the whole story of patient involvement in the study Standards by which study information should be recorded and maintained GDP parameters Record entries when you do the activity Dates and signatures Pen only – no pencil or erasable pen English No white-out Only sign off on work you have done yourself Do not backdate Do not throw out original data – if it's a post-it or scratch paper it must stay in https://www.pharmaguideline.com/2014/07/requirements-for-good-documentation-practice-gdp.html ALCOA-C Attributable – clear who did what, traceable to a person and date Legible – easy to read what is written Contemporaneous – document things in real time as they happen Original – file the first recording of the information Accurate – real representation of what happened Complete – information answers who, what, when, where, why, and how https://www.uhhospitals.org/-/media/Files/For-Clinicians/Research/alcoac-documentation.pdf ALCOA-C and Source Documents ALCOA-C applies to every piece of data collected in the study "Source documents" are the original source documents from which data for the study is collected, e.g. medical records, other notes taken clinically or in research, interview notes, etc. Study should retain the source documents. Best practice is to retain PDF (if electronic) or paper copies (if paper chart) with the source documents used Correcting study information Sometimes happens Do not erase or otherwise obscure the original information Cross out the initial information with one line and initial Make a note as to why changing Ensure only people who are delegated (on DOA) to do so make changes Essential regulatory documents What are regulatory documents What do we mean by this? In my experience, different people have different definitions Sometimes they mean IRB documents, signed consent forms Others refer to them to include patient files Often managed by the CRC but important for the CRM/PM to know what is needed Regulatory documents "...those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements." In other words, you should have all of these documents in place for each study that you do Usually there are both paper (for original signatures) and electronic versions. Some Sponsors are moving to all electronic. The Ohio State University Center for Clinical and Translational Science. Regulatory Documents. https://ccts.osu.edu/content/regulatory-documents Tips for startup – Creating regulatory binders Usually the Sponsor will give you a list of all documents that they need. Sponsors often provide binders (paper or electronic) to organize essential documents This is in addition to the site keeping up its own patient, IRB, personnel, lab, and other files Start a study file system at outset of trial CFR and ICH E6 Guidance for GCP summarizes documents needed There may be some variations from study to study but usually the core documents are the same Regulatory Binder – Contents snapshot Protocol, IBMonitor logsScreening and enrollment logs ICFMonitor correspondenceAds and other recruitment materials IRB correspondenceFinancial/contract documentsParticipant tracking logs Event reporting logs, protocol deviations, NTFsPersonnel documents (cv's, HSP, license, training, GCP, FDF)Participant eligibility criteria, consent forms DOAQueries and resolutionCRFs, source documents 1572Lab documentation – personnel, study drug tracking, temperature logs...Letters and correspondence Essential Documents – 3 time periods Before the clinical trial starts During the conduct of the trial At the end of the trial GCP-Mindset – All About Clinical Research. “Basics – Part 22 – Essential Documents.” https://www.youtube.com/watch?v=9_cBEDpzym4 Locations of essential documents Trial Master File (TMF) – at Sponsor Investigator Site File (ISF) – at study site Some documents are in one or the other, some are in both. For example patients files including source documents are all in the ISF; both places will have the eCRFs Study sites should keep all materials in their files, and send copies of certain materials to sponsor Patient identifiers stay at study site. Always  redact documents for PHI before sending to sponsor. Essential documents prior to study Study startup documents Financial agreements IRB documentation Study team documents Site implementation documents Lab documents Next I will cover each of these in more detail... Study startup documents (prior to study) FDA form 1572 - PI assures they are ultimately responsible for the conduct of the study Letter of Agreement (LOA) between investigator and sponsor and/or Protocol signature sheet (signed and dated by PI) Investigator Brochure (signature page/receipt form signed) - scientific data and rationale for study Delegation of Authority log (DOA) 2. Financial Agreements (prior to study) CDA (confidentiality disclosure agreement) CTA/MCTA (contract) Subcontracts (with any other sites involved in the work) Insurance statement (what will be covered as SOC versus research) Any signed agreements Usually these financial documents are stored in a secure location separate from the ISF 3. IRB documents (prior to study) IRB initial approval IRB approved protocol Informed consent form (ICF) Recruitment materials IRB FWA # or membership roster 4. Study team member documents (prior to study) curriculum vitae (CV) (signed and dated) GCP training (signed and dated) Human Subjects Protection (HSP) training (signed and dated) Medical license (if applicable) Proof of insurance (if applicable) Sign the delegation of authority log before engaging in study activities Financial Disclosure Forms (FDFs) Documentation of study-related training (procedures, EDC, etc.) 5. Site implementation documents (prior to study) Site Information Sheet or Contact Info sheet (sent to sponsor so they know whom to contact for what) Sample Case Report Forms (CRFs) 6. Lab documents (prior to study) Laboratory certification and accreditation (CLIA/CAP) CLIA is Clinical Laboratories Improvement Act of 1988 CAP is the College of American Pathologists Usually good for 2 – 3 years Lab normal ranges form – a reference point for study participant lab values CVs and medical license of laboratory director or pharmacist Sample labels Essential documents during study IRB or regulatory documentation (ongoing) Study team documentation (updates) Study enrollment information Patient files Site implementation documents Lab documentation Next I will cover each of these in more detail... 1. IRB or regulatory documentation (during study) Any changes to 1572 Continuing review reports (CRRs) and progress reports Any amendments or protocol modifications approved by the IRB Include ICF changes, recruitment materials, etc. IRB correspondence (include all letters and emails) SAE reporting records IND safety reports Protocol deviations reported 2. Study team member documentation (during study) Curriculum vitae (updated every 2 years) GCP training (updated every 3 years) Human Subjects Protection (HSP) training (updated every 3 years) Medical license (usually every 4 years) Be sure to both update these documents for existing team members, and gather these documents for any new team members before they start work on the study 3. Study enrollment information (during study) Screening log – document all patients screened for enrollment whether enrolled or not Enrollment log – "Confidential Master Subject Log" - all patients consented and enrolled Withdrawal log – document all patients withdrawn or lost to follow up 4. Patient files (during study) Signed informed consent forms (kept in one central location, or in individual patient file) Visit or monitoring forms Source documents (copies in patient file and/or planned access to electronic files) Any data capture forms; any document where original data is recorded CRFs or copies of eCRFs including initial version and any edits AEs and SAEs (and record of notification of sponsor, and IRB if applicable; sponsor keeps records of notification to FDA) Protocol deviations Institutions may require documentation of study participation in the medical record 5. Site implementation documents (during study) Monitoring letters and reports Site visit log (monitor visits) Sponsor correspondence Queries and resolution of queries 5. Lab documentation (during study) Shipment, receipt, and dispensing of the study drug ("test article") Temperature records Investigational product accountability log/study drug accountability records Certificate of Analysis Updated lab certifications (CLIA, CAP) Any updates to lab abnormal values Essential documents after study Study drug destruction documentation All participant data forms Any outstanding queries Test article accountability records Final Reports from PI to IRB and Sponsor Final Financial Disclosure Report PI status change report if applicable Retain documents for at least 2 years following NDA approval Key documents (listed in above slides) to send to sponsor (TMF) during study Protocol amendments and continuing review approvals 1572 if any changes cv's, licenses, training for existing and any new staff/investigators Updated lab certifications and normal ranges Any new recruitment materials Liu & Davis. pp. 256 - 258 Key documents (listed in above slides) to maintain at study site (ISF) during study IRB correspondence Screening log Enrollment log Signed consent forms Study drug shipping, receiving, storage, dispensing logs (usually kept by IDS) SAE and AE forms and reporting records Data forms and queries Source documents Site visit and monitor logs Managing Patient Files Study participant files Participant ID Every study should have a unique ID for each participant ID should be random and not linked to any identifiers (like initials) Coded list or information linking IDs to patient names should be locked/secured and only accessible to study team Participant ID should be used on all forms, lab tubes, etc. Every page. Patient names and other PHI should be redacted from source documents before sending to study sponsor, coordinating center, etc. Original consents and source documents with patient identifiers should be stored securely in local patient files Source documents These are the original documents from which the data for a study has been gathered May be an electronic source such as medical records or a paper source such as a survey or interview notes Best practice is to keep copies of source documents in your patient files Patient files can be electronic and/or paper Emails to participants may be considered source documents and filed in patient file Use source documents to double check any queries that arise from data entered documents Must be available for monitors, inspectors, auditors to check validity of data Examples of Source Documents Medical records Conmeds – concomitant medications – any other medications patients are taking while in the study Vital signs Testing results like ECG or other Lab results Patient questionnaires Maintaining study files One file or binder for each patient Multiple files for various regulatory documents Maintain chronological order Separate into sections per data collection windows or activities Aim to maintain while you conduct study activities Regulatory Resources Regulatory binder checklist https://files.nccih.nih.gov/s3fs-public/CR-Toolbox/Regulatory_Binder_Checklist_ver3_07-17-2015.docx Essential documents for the conduct of a clinical trial https://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial  Notes to File guidance https://files.nccih.nih.gov/s3fs-public/CR-Toolbox/Notes_To_File_Guidance_07-17-2015.docx 12 Items auditors look for https://www.advarra.com/blog/12-items-auditors-look-for/ someTitle 3 Sponsor,Site,andStudyStart-Up The cost of developing and bringing a new drug tomarket is extremely high. In a 2014 study by theCenter for the Study ofDrugDevelopment at TuftsUniversity, the cost of bringingasingledrugtomarketwasestimatedatUS$2.558billion(DiMasi,Grabowski,& Hansen,2016,p.25).Ofthatamount,approximatelyUS$1.460billionwasattributedtothe costofconductingclinicaltrials(DiMasietal.,2016,p.25).Withthisamountofmoneyat stake,sponsorsaremotivatedtocollaboratewithresearchsitesthatarepreparedandready to initiate a clinical trial in a timelymanner once the clinical trial protocol and related documentsareapprovedbytheinstitutionalreviewboard(IRB). Thischapterreviewsthevariousstepsandactivitiesthatneedtooccurattheresearch sitepriortostartingtheclinicaltrial.Wereviewtheformsanddocumentsrequiredofthe investigator/research site to start a clinical trial and describe the Statement of the Investigator in detail because it is the investigator’s commitment to conduct the clinical trialinaccordancewithallapplicablelawsandregulations. RESEARCHSITESTART-UPRESPONSIBILITIES Theresearchteamhasobligationsandtasksthatmustbecompletedbeforeaclinicaltrialis started.Theresearchteammustprovidethesponsorwithrequireddocumentsandcomplete thenecessaryresearchsiteset-upactivitiesbeforeclinicaltrialstart-up.Theseincludethe following: 1. CompleteandsubmitFormFDA1572.
Answered 2 days AfterJul 05, 2022

Answer To: Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for...

Insha answered on Jul 07 2022
80 Votes
Running Head: Clinical Research Manager                  1
Clinical Research Manager                             8
CLINICAL RESEARCH MANAGER
Table of Contents
Slide 1: Title    3
Slide 2: Management of team's study files and essential documents    3
Slide 3: Review and completion of the study's documentation    3
Slide 4: Designing databases    4
Slide 5
: Data gathering    5
Slide 6: CRF monitoring    5
Slide 7: Input information    5
Slide 8: Validation of data    6
Slide 9: Discrepancy control    6
Slide 10: Healthcare coding    7
Slide 11: Securing a database    7
Slide 12: Responsibilities and roles    8
Slide 13: Conclusion    9
Slide 14: References    10
Slide 1: Title
· Title:
Slide 2: Management of team's study files and essential documents
· Tools
· Review and completion of the study's documentation.
· Designing databases.
· Data gathering.
· CRF monitoring.
· Input information.
· Validation of data.
· Discrepancy control.
· Healthcare coding.
· Securing a database.
· Responsibilities and roles.
Data collection, cleansing, and management (CDM) is the procedure for gathering, managing, and handling subject data in accordance with legal requirements. The main goal of CDM procedures is to produce high-quality data while collecting the most data feasible for analysis. This is done through minimizing mistakes and missing data. This article outlines the CDM procedures and provides an overview of clinical trial data management.
Slide 3: Review and completion of the study's documentation
· As the initial stage in converting the protocol-specific actions into data being created, the CDM team designs a Case Report Form (CRF).
· The data fields should have uniform definitions across the board.
· In CDM tools, variables are identified via annotations, which are coded phrases.
· All potential answers will be suitably coded in questions with discrete value alternatives.
· The data handling process is mapped out in a data management plan (DMP).
The procedure is examined for consistency and clarity from the standpoint of database design. As the initial stage in converting the protocol-specific actions into data being created, the CDM team designs a Case Report Form (CRF) (Zhuang et al. 2022). The data fields should have uniform definitions across the board. For instance, the data entry field should have two data boxes positioned after the decimal if weight must be recorded to two decimal places.
In CDM tools, variables are identified via annotations, which are coded phrases. The variable is named using either internal naming standards or the SDTMIG when CRF annotation is performed (Wake Health). All potential answers will be suitably coded in questions with discrete value alternatives, such as the variable gender, which accepts the values male and female as responses. The data handling process is mapped out in a data management plan (DMP).
Slide 4: Designing databases
· Databases are created to make it easier for the CDM duties to conduct several researches.
· To guarantee data security, "system validation" is carried out, during which system specifications
· The database contains defined study information, and CRF layouts are created for data entry.
· Before being used for real data gathering, these input screens are validated using fake data.
The clinical software programs known as databases are created to make it easier for CDM to do several investigations. Data security is ensured through a process known as "system validation," which involves assessing the system needs and regulatory standards (Zhuang et al. 2022). The database contains study details such as objectives, intervals, visits, investigators, sites, and patients, and CRF layouts are built for data entry.
Slide 5: Data gathering
· Data is gathered using the CRF.
· The typical way of collecting data responses is to use paper CRFs, which...
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