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Manual of Procedures for Protocols

By Vanessa Woods,2014-06-23 22:00
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Manual of Procedures for Protocols

    Manual of Procedures Version <0.0>

    

    Tool Summary Sheet

    Tool: Manual of Procedures (MOP) Template

    Purpose: This document provides a template to assist investigators with the

    preparation of a study Manual of Procedures (MOP). The purpose

    of the MOP is to facilitate consistency in protocol implementation

    and data collection across participants and clinical sites. Use of

    the MOP increases the likelihood that the results of the study will

    be scientifically credible and provides reassurance that patient

    safety and scientific integrity are closely monitored.

    Audience/User: Investigators and Study Coordinators may use this template as a

    basis for customizing an appropriate Manual of Procedures to

    support individual studies.

    Details: A MOP (also known as Manual of Operations [MOO]) is a

    handbook that guides a study’s conduct and operations. It

    supplements the study protocol by detailing a study’s organization,

    operational data definitions, recruitment, screening, enrollment,

    randomization, intervention procedures and follow-up procedures,

    data collection methods, data flow, Case Report Forms (CRFs),

    and quality control procedures. Procedures in the MOP should be

    followed with the same degree of vigor as those documented in

    the protocol.

    Best Practice ; Review this template and customize to the specific needs

    Recommendations: and requirements of the study. Sample text may be

    updated as needed. Remove or mark as “not applicable”

    those elements that are not required.

    ; In the template, the instructions and explanatory text are

    indicated by {blue italics} (“CROMS_Instruction” style).

    Instructional text will also be enclosed in braces to signify

    this text for screen-readers used by the visually impaired.

    ; Text enclosed with <> is a placeholder for a specific detail

    (e.g., ); replace as appropriate.

    ; Because the MOP is used in tandem with the protocol, it is

    not necessary to repeat major sections of the protocol in

    the MOP (e.g., the summary of events). It is also good

    practice to avoid redundancy within the MOP itself. In both

    cases, use document and section references when

    necessary, remembering to revise these references when

    either document is updated.

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    ; The first version of the MOP should be available at the time

    of study start.

    ; Sections of the MOP should be prepared by the subject

    matter experts (e.g., clinical procedures should be prepared

    by a clinician and data management procedures should be

    written by the data manager).

    ; The MOP is a dynamic document and tends to be updated

    more frequently than the protocol. Ensure that the MOP

    has a section on version control of the document and

    dissemination of updated versions.

    ; It is easiest and cleanest to use the styles that are

    embedded in the document, rather than to create your own.

    (In MS Word 2007: From the Home menu, select the

    bottom right arrow key to bring up the styles box, select

    “Options”, under “Select Styles to Show” select “in current

    document”.

    ; Please retain the MOP Template identifier in the lower left

    hand section of the footer.

    Tool Revision History:

    Version

    Number Date Summary of Revisions Made:

    Version 2.0 01OCT2010 Approved version. Includes styles and

    accommodations for 508 compliance.

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    {Instruction: Delete the Tool Summary Sheet and this Preface at the time of study-specific implementation.

    Preface to the Manual of Procedures Template

    Version 2.0 (24 September 2010)

    Purpose of the Manual of Procedures (MOP)

    A Manual of Procedures (MOP) is a handbook that guides a study’s conduct and operations. It supplements the study protocol by detailing a study’s organization,

    operational data definitions, recruitment, screening, enrollment, randomization, intervention procedures and follow-up procedures, data collection methods, data flow, Case Report Forms (CRFs), and quality control procedures. The purpose of the MOP is to facilitate consistency in both protocol implementation and data collection across participants and clinical sites. Use of the MOP increases the likelihood that the results of the study will be scientifically credible and provides reassurance that participant safety and scientific integrity are closely monitored.

The MOP Template and Mechanics

    This MS Word template can be used as the starting point for development of a study-specific MOP.

    In the template, the instructions and explanatory text are indicated by {blue italics}

    (“CROMS_Instruction” style). Instructional text will also be enclosed in braces to signify this text for screen-readers used by visually impaired persons.

    This text should be deleted during the study-specific customization of the MOP. Example text that appears in the MOP template in regular font may be retained and edited as appropriate to the study. Text within any section should be formatted using CROMS_Text style. Bulleted lists should be formatted using CROMS_Text Bullet (listing) style. Text included in <> is a placeholder for a specific detail (e.g., title>); replace as appropriate. Use CROMS_Heading1-5 to format headings. The MOP sections listed and described in the template are intended as guidelines and should be adapted to each study’s specific needs. If a section in the template does not apply to a study (e.g., randomization in a study with no randomization), it should not be included in the MOP.

    Refer questions regarding use of this Manual of Procedures template to the appropriate NIDCR Program Official or the NIDCR Office of Clinical Trials Operations and Management (OCTOM).

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A number of useful tools are available in the NIDCR website

    (http://www.nidcr.nih.gov/Research/toolkit/) and Clinical Tool Box section of the CROMS

    website. Please peruse the website to identify those that would be applicable for your study. Several of those tools are also referenced in the MOP template. Please note that all hyperlinks were functional at the time this template was published. If you find a link that is no longer active, please feel free to email anyone on the CROMS team, and it will be corrected with the next release of the template.

MOP Development

    Because the MOP is used in tandem with the protocol, it is not necessary to repeat major sections of the protocol in the MOP (e.g., the summary of events). It is also good practice to avoid redundancy within the MOP itself. In both cases, use document and section references when necessary, remembering to revise these references when either document is updated.

    The primary audience for the MOP is the site investigators and other research staff. Administrative documents, such as the data management plan, safety management plan, or statistical analysis plan are not commonly included in the MOP. Instead, only the site-relevant details are captured in the MOP and the other documents are maintained separately. These documents may be referred to in the MOP as “dynamic

    references.”

    Development of the MOP requires the involvement of investigators and study staff (clinicians, laboratory staff, pharmacists, statistician data manager, regulatory specialist, etc.) to ensure that the guidelines accurately reflect how the study procedures will be performed. In multi-site clinical studies, a Steering Committee, comprised of the Principal Investigators from each of the sites, is often appointed to finalize the protocol and elements of the MOP.

    The MOP finalization requires completion of the final protocol, CRFs, informed consent documents, and administrative forms (e.g., subject screening log, subject enrollment log, delegation of responsibilities log, etc.). Additionally, if the study is to be submitted to the Food and Drug Administration (FDA) under an Investigational New Drug Application (IND), an Investigator's Brochure, package insert or comparable product description may be required. Development of study materials could take up to six months. The MOP must be completed and be available to study staff before a study commences; please plan accordingly.

    The National Institute of Dental and Craniofacial Research, National Institutes of Health (NIH) must ensure compliance with Federal laws and regulations, including procedures and policies to protect the safety of all participants in the clinical studies it supports. In preparing a study protocol and a Manual of Procedures (MOP), the NIDCR grantee must be aware of the terms of award with respect to required reporting, data and safety monitoring, and Institutional Review Board (IRB) approval. For additional information, Template Version 2.0-20101001

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see website below:

    http://www.nidcr.nih.gov/ClinicalTrials/ToolkitClinicalResearchers/PoliciesGuidance/NIDCRClinicalTermsofAward.htm

Maintenance and Updating of the MOP

    The MOP should be maintained in a format that allows it to be easily updated; it may be filed in a three-ring binder, separated by dividers or sheets of paper, or stored in electronic format.

    The MOP is a dynamic document that will be updated throughout the conduct of a study to reflect any protocol or consent amendments as well as the refinement of the CRFs and study procedures. It is useful to maintain a log in the front of the MOP that summarizes changes to the document. As sections/chapters are revised, update the MOP version number and date on the cover page and Table of Contents; use the Summary of Changes table on the cover page to list the chapters that have changed and to provide a general summary of those changes. You may choose to update the version date on all pages or only on those chapters that have been modified, for ease of identification. Make note of the chosen strategy in the version control section of the MOP. All previous versions should be archived.

    Instruction: End of Preface. To be deleted at the time of study specific implementation.} Template Version 2.0-20101001

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    Manual of Procedures (MOP)

    for

    

    NIDCR Protocol Number: <#>

    Draft or Version Number: <#.#> {0.x (for draft) or x.0 (for final) Refer to NIDCR Guidance for assigning version numbers;

    when the version number and date change, be sure to update them in the header of

    every page of the MOP.}

    

{(e.g., 23 January 2010)}

    Summary of Changes:

    Number Date Affected Summary of Revisions Made:

    Chapter(s)

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    Table of Contents

    Page

    1 Introduction to the Manual of Procedures.............................................................. 12 1.1 Purpose ...................................................................................................... 12 1.2 Updating and Version Control .................................................................... 12

    2 Administrative ........................................................................................................ 13 2.1 Study Leadership Structure ........................................................................ 13

    2.1.1 Organizational Chart ........................................................................ 13

    2.1.2 Roles and Responsibilities ............................................................... 13

    2.1.3 Steering Committee ......................................................................... 14 2.2 Policies and Procedures ............................................................................. 15

    2.2.1 Conflict of Interest (COI) and Financial Disclosure Policies ............. 15

    2.2.2 Protocol Amendment Procedures .................................................... 15

    2.2.3 Version Control of Study Documents ............................................... 15

    2.2.4 Communication Plan ........................................................................ 15

    2.2.5 Clinical Trial Registry/ClinicalTrials.gov and PubMed ...................... 18

    2.2.6 Data Request Policy ........................................................................ 19

    2.2.7 Publication and Presentation Policy ................................................. 19

    2.2.8 Organizational Chart ........................................................................ 19

    2.2.9 Roles and Responsibilities ............................................................... 19

    2.2.10 Qualifications ................................................................................... 20 2.3 Safety Oversight Committee ....................................................................... 20

    2.3.1 Roles and Responsibilities ............................................................... 20

    2.3.2 Membership ..................................................................................... 20

    2.3.3 Frequency of Meetings .................................................................... 20 2.4 Scientific Advisory Board ............................................................................ 20

    2.4.1 Roles and Responsibilities ............................................................... 20

    2.4.2 Membership ..................................................................................... 21 2.5 Community Advisory Board ........................................................................ 21

    2.5.1 Roles and Responsibilities ............................................................... 21

    2.5.2 Membership ..................................................................................... 21

    3 Regulatory ............................................................................................................. 22 3.1 Regulations and Regulatory Bodies ........................................................... 22 3.2 Federal Wide Assurance Documentation ................................................... 22 3.3 Protection of Human Subjects .................................................................... 23

    3.3.1 Informed Consent / Assent Process ................................................ 23

    3.3.2 Documentation of Consent / Assent ................................................ 24

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    3.3.3 Translation of Informed Consent and Assent Forms ........................ 24

    3.3.4 Re-consenting for Protocol Changes or Safety Updates ................. 24

    3.3.5 HIPAA Privacy Rule ......................................................................... 25

    3.3.6 Required Documents ....................................................................... 25

    3.3.7 Document Maintenance ................................................................... 26

    4 Site Quality Management Plans ............................................................................ 27 4.1 Informed Consent ....................................................................................... 27 4.2 Data Management ...................................................................................... 27 4.3 Research Specimen Management ............................................................. 27

    5 Site Preparation .................................................................................................... 28 5.1 Facilities Requirements .............................................................................. 28

    5.1.1 Clinical Research Area .................................................................... 28

    5.1.2 Secure Document Storage............................................................... 28

    5.1.3 Diagnostic Services ......................................................................... 28

    5.1.4 Pharmacy Services .......................................................................... 29

    5.1.5 Laboratory Services ......................................................................... 29

    5.1.6 Courier Services .............................................................................. 29

    5.1.7 Research Sample Storage ............................................................... 29 5.2 Staff Training .............................................................................................. 29

    5.2.1 Human Subjects Protection Training ............................................... 29

    5.2.2 Good Clinical Practice Training ........................................................ 29

    5.2.3 Protocol Training .............................................................................. 29

    5.2.4 Study-Specific SOP Training ........................................................... 30

    5.2.5 Clinical Operations ........................................................................... 30 5.3 Equipment and Supplies ............................................................................. 30

    6 Protocol Implementation........................................................................................ 31 6.1 Recruitment, Screening, and Enrollment .................................................... 31

    6.1.1 Recruitment Methods ....................................................................... 31

    6.1.2 Pre-Screening .................................................................................. 31

    6.1.3 Screening......................................................................................... 31

    6.1.4 Rules for Re-screening .................................................................... 31

    6.1.5 Establishing Eligibility ...................................................................... 31

    6.1.6 Assigning Participant Identification (PID) Numbers ......................... 31 6.2 Enrollment Procedures ............................................................................... 31 6.3 Randomization............................................................................................ 32 6.4 Blinding/Masking ........................................................................................ 32 6.5 Detailed Description of the Study Intervention ............................................ 32 6.6 Detailed Description of Study Procedures .................................................. 32

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    6.6.1 Schedule of Events .......................................................................... 33

    6.6.2 Visit Windows .................................................................................. 33

    6.6.3 Rules for Rescheduling Visits .......................................................... 33

    6.6.4 Order of Visit Activities ..................................................................... 33

    6.6.5 Rules for Rescheduling Events ........................................................ 33

    6.6.6 Missed Visits and Procedures.......................................................... 33 6.7 Protocol Deviations and Violations ............................................................. 33 7 Procedures for Monitoring Trial Progress .............................................................. 33 7.1 Enrollment .................................................................................................. 33 7.2 Visit Completion.......................................................................................... 33 7.3 Outstanding and Missing Data ................................................................... 33 7.4 Data Entry Errors ........................................................................................ 33 7.5 Protocol Deviations/Violations .................................................................... 34 7.6 Serious Adverse Events ............................................................................. 34 8 Test Article ............................................................................................................ 35 8.1 Obtaining Test Article ................................................................................. 35 8.2 Storage Conditions and Stability................................................................. 35 8.3 Reconstitution (if applicable) ...................................................................... 35 8.4 Ordering Test Article ................................................................................... 35 8.5 Dispensation of Test Article to Clinical Staff ............................................... 35 8.6 Treatment Regimen and Administration ..................................................... 35 8.7 Participant Counseling ................................................................................ 35 8.8 Monitoring Subject Compliance .................................................................. 35 8.9 Test Article Accountability .......................................................................... 35 8.10 Return and Destruction of Test Article after Study Completion .................. 35 8.11 Compliance with Good Manufacturing Practice Standards ......................... 35 9 Safety Assessment and Reporting ........................................................................ 36 9.1 SAE Reporting ............................................................................................ 36 9.2 Expected Adverse Events .......................................................................... 36 9.3 Toxicity Tables............................................................................................ 36 9.4 Prohibited Medications ............................................................................... 36 9.5 Unanticipated Problems ............................................................................. 36 9.6 Pregnancy Testing and Counseling ............................................................ 36 10 Data Management ................................................................................................. 37 10.1 Data Collection Methods ............................................................................ 37 10.2 Source Documentation Requirements ........................................................ 37 10.3 Study Forms ............................................................................................... 38 10.4 Case Report Form Completion Guidelines ................................................. 38 Template Version 2.0-20101001 9

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    10.5 Data Error Detection and Correction .......................................................... 38 10.6 Data Quality Management .......................................................................... 38 10.7 Data Provided from an Entity other than the Clinical Site ........................... 38 10.8 Data Collection and Data Processing Flowchart ........................................ 39 10.9 Creating and Distributing Revised Case Report Forms .............................. 39 10.10 Long Term Storage of Case Report Forms ................................................ 39 10.11 Maintaining Data Privacy ............................................................................ 39

    11 Specimen and Laboratory Management ............................................................... 40 11.1 Specimen Collection ................................................................................... 41

    11.1.1 Overview .......................................................................................... 41

    11.1.2 Detailed Information for Each Specimen ......................................... 41

    11.1.3 Specimen Tracking .......................................................................... 41 11.2 Overview of Tests to be Performed in Each Lab ........................................ 41 11.3 Laboratory Staff .......................................................................................... 41

    11.3.1 Roles and Responsibilities ............................................................... 41

    11.3.2 Good Clinical Lab Practice Training ................................................. 41

    11.3.3 IATA Training and Certification ........................................................ 41 11.4 Laboratory Certifications and Quality Assurance Plans .............................. 41 11.5 Laboratory Procedures ............................................................................... 41

    11.5.1 Specimen Acquisition ...................................................................... 41

    11.5.2 Specimen Storage and Tracking ...................................................... 41

    11.5.3 Detailed Instructions for Processing Individual Specimen Types ..... 41

    11.5.4 Laboratory Data Management and Storage ..................................... 42

    12 Site Monitoring ...................................................................................................... 43 12.1 Purpose of Site Monitoring ......................................................................... 43 12.2 Clinical Monitoring Logistics ....................................................................... 43

    12.2.1 Frequency of Visits .......................................................................... 44

    12.2.2 Scope of Monitoring Activities .......................................................... 44

    12.2.3 Monitoring Reports .......................................................................... 44

    12.2.4 Communication Plan ........................................................................ 44 12.3 Facilitating the Site Monitoring Visit ............................................................ 44

    12.3.1 Scheduling the Visit ......................................................................... 44

    12.3.2 Securing Space for Monitors............................................................ 44

    12.3.3 Preparing Study Documentation for Review .................................... 44

    12.3.4 Arranging for Access to Medical Records ........................................ 44

    12.3.5 Wrap-Up Meeting ............................................................................. 44

    12.3.6 Responding to Request for Corrective Action .................................. 44 12.4 Preparing for Audits by Regulatory Authorities ........................................... 44

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