Accelerating product development may 15 2014 imdmc reg 101
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Accelerating Product Development May 15, 2014 IMDMC Reg 101. IDEs (Investigational Device Exemptions) Clinical Trials IRBs (Institutional Review Boards). What we will cover today. 21 CFR 50 Protection of Human Subjects 21 CFR 54 Financial Disclosure

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Accelerating Product Development

May 15, 2014

IMDMC Reg 101

  • IDEs (Investigational Device Exemptions)

  • Clinical Trials

  • IRBs (Institutional Review Boards)

What we will cover today

  • 21 CFR 50 Protection of Human Subjects

  • 21 CFR 54 Financial Disclosure

  • 21 CFR 56 Institutional Review Boards

  • 21 CFR 58 Good Laboratory Practices for nonclinical lab studies

  • 21 CFR 312 Good Clinical Practices (GCP)

  • 21 CVR 812 Investigational Device Exemptions

  • 21 CFR 820.20 Design Controls of the Quality System Regulation

Primary Regulations

  • Significant versus Non-Significant Risk

  • Do not need to submit an IDE prior to initiating clinical investigations for nonsignificant risk devices

    • Still need to meet a number of other regulatory requirements in 21 CFR 812

    • Advisable to submit protocol to FDA even though not required

IDE Exemptions

  • IVDs (in vitro diagnostics), if:

    • Testing is non-invasive

    • Does not requires invasive sampling presenting significant risk

    • Does not introduce energy into a subject

    • Is not used as a diagnostic procedure without confirmation be another, medically established diagnostic device or procedure

IDE Exemptions

  • Preamendment devices

  • Substantially equivalent devices

  • Consumer preference testing

  • Veterinary use – Watch USDA

  • Lab animal / research use

  • Custom device

  • Check the FDA guidance

IDE Exemptions

If not exempt:

  • Preliminary Design finalized

  • Lab tests (non-human) performed under GLP

  • File for IDE

  • Clinical Trials – tests in human performed under GCP and IRB

Typical Path

  • Investigational Device Exemptions

    • Must be submitted to the FDA, and approved prior to performing any clinical trials in humans

  • 30 day review process at FDA

  • IRB approval

IDE Process

  • Sponsor information

  • Complete report of prior investigations of device

    • laboratory and/or animal testing performed

  • Manufacturing

    • methods, facilities, controls, etc.

  • Investigator agreements, names, and addresses

    • Certification that all investigators have signed the agreement, and that none will be added until they have signed

  • Institutions

Contents of an IDE

  • Informed consent materials

  • If device will be sold, how much will be charged

  • IRB(s) information

    • Name

    • Address

    • Chairperson

  • Labeling

    • Name and address of manufacturer

    • Quantity of contents

    • Statement of effectiveness

    • Cautions

Contents of an IDE

  • Changes requiring prior approval by FDA and IRB

  • Change effected for emergency use, report within 5 days

  • Changes effected with notice to FDA within 5 days

  • Annual report

  • Addition of Institutions

Maintenance of an IDE

  • Identify intended use

  • Demonstrate safety and effectiveness

  • Train, train, train

  • Anticipate complications

  • Address potential issues

  • Monitor for compliance to protocol and adverse reactions

Clinical Trials

  • Number of investigators required

  • Development of protocols

  • Study hypothesis

  • Control group

  • Eligibility criteria

  • Assignment of intervention

  • Sample size

  • Endpoints

Clinical Trial Design Considerations

  • Blinding / Masking

  • Comparability of patients in study groups

  • Other

    • Number of sites

    • Duration of study

    • Selection of investigators who are sufficiently qualified

    • Ensure informed consent is obtained

Clinical Trial Design Considerations

  • Statement that study involves research

    • Purpose

    • Expected duration

    • Identification of procedures to be followed

    • Identification of any procedures that are experimental

  • Description of any reasonably foreseeable risks or discomforts to the subject

Informed Consent - Elements

  • Check FDA regulations for required elements

  • Description of any benefits to the subject that may reasonably be expected

  • Disclosure of appropriate alternative procedures or courses of treatment

  • Statement describing the extent of confidentiality of patient records

  • Explanation of whom to contact

    • Questions about the research and/or rights

    • In the event of research-related injury

Informed Consent - Elements

  • For research involving more than minimal risk, an explanation as to whether any compensation and any medical treatments are available should injury occur, and if so, what they consist of, or where further information may be may be obtained

  • Statement:

    • Participation is voluntary

    • Refusal to participate will not involve penalty or loss of benefits

    • Subject may discontinue participation at any time

Informed Consent - Elements

  • Where appropriate

    • Statement regarding risks to embryo or fetus, should participant become pregnant

    • Anticipated circumstances under which the patient may be terminated from the study

    • Any additional costs to the subject

    • Consequences of a subject’s decision to withdraw from study, and procedures for termination of participation

    • Statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to participate will be provided to the subject

    • Approximate number of subjects in the study

Informed Consent - Elements

  • Main parties involved:

    • Sponsor

    • Investigator

    • IRB

  • Roles and responsibilities

Clinical Trial

Individual, company, institution or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial

  • Provides the overall design and control of trial


  • Trial design

  • Trial management, data handling, record-keeping

  • Quality assurance / quality control

  • Medical direction and expertise

  • Investigator selection

  • Allocation of responsibilities

  • Financing

  • Notification / Submission

  • Confirmation of IRB review

  • Information about Investigational Product

Sponsor Responsibilities

  • Investigational product management

  • Providing record access

  • Safety informatiion

  • Adverse event reporting

  • Monitoring

  • Auditing

  • Dealing with Non-compliance

  • Suspension / Early termination of a trial

  • Trial reporting

Sponsor Responsibilities

Person responsible for the conduct of a clinical trial at a trial site

  • Recruits subjects

  • Treats subjects in accordance with the protocol

  • Gathers necessary data

  • Provides data to sponsor


  • Adequate resources

  • Medical care of the subjects

  • Communication with the IRB

  • Compliance with the protocol

  • Accountable for investigational products

  • Randomization procedures and unblinding

  • Informed consent of trial subjects

  • Records and reports

Investigator Responsibilities

A board, committee, or other group formally designated by an institution to review, approve the initiation of and conduct periodic review of biomedical research involving human subjects.

  • Safeguard the rights, safety, and well-being of human subjects


  • Approval, disapproval, modification or suspension of clinical trials

  • Qualifications of investigator for the proposed trial

  • Determination that proposed protocol adequately addresses relevant ethical concerns and meets applicable regulatory requirements

  • Review progress of trial on periodic basis (no less than annually)

  • Develop and maintain required records and documents

IRB Responsibilities

  • Review of consent:

    • Confusing or exculpatory language

    • Required elements

    • Alternate consent schemes (e.g. verbal)

    • Special protections for vulnerable populations

    • Ensure that information regarding payment to subjects is specified in informed consent or other documents

  • Review amount and method of payment to subjects to ensure that neither presents undue influence or coercion

IRB Responsibilities

  • Maintain a balanced and diverse board, consisting of a minimum of 5 members:

    • One non-scientific member

    • One member not related to the institution

    • One scientific member

    • In the case of special population, an individual sentsite to the needs of that population to be at least brought in as a consultant when needed

IRB Responsibilities

  • Relatively new paradigm

  • Serve as Central IRB

  • Cooperative review with local IRBs

  • Simplifies bringing on new sites

  • FDA proposed change to common rule

Commercial IRBs

  • Questions?


  • Diana Caldwell, MBA: President & CEO

    • Accomplished life science business leader with over 20 years of experience in both large pharmaceutical and small entrepreneurial environments

    • Successfully driven organizational growth and product development plans

    • Leads company and all business support functions

  • Gretchen Bowker, MS, RAC: COO

    • Protein chemist with over 25 years experience in the development of drugs, biologics and devices

    • Recognized leader in regulatory, bioethics, and compliance

    • Extensive experience in working within institutions, large pharmaceutical companies, small biotechs, and large device companies

    • Track record of assembling teams of experts, developing processes and procedures, and implementing strategic plans which ensure successful development of drug, device and diagnostic products

    • Leads all client service delivery

About our founders

  • Diana Caldwell, President & CEO


  • Gretchen Bowker, Chief Operating Officer


  • Contact us at 317.899.9341

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