Sandra Maddock & Brandy Smith BioEnterprise Presentation 9.6.12

The Difference is
in the Details

Drugs vs.
Devices
Presented by:
Brandy Smith
Sandra Maddock

We have studied clinical research and regulatory compliance
issues since 1999.

Agenda
An Overview of Drugs and Devices

Determining the Need for a Clinical Trial

Regulatory Overview

Clinical Trial Similarities

Clinical Trial Differences

FAIR Shake™- The Regulations

Overview of Drugs and Devices
Drugs
Articles recognized in the official US
Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the US, or official National
Formulary
• intended for use in the
diagnosis, cure, mitigation, treatment, or prevention
of disease
• intended to affect the structure of any function of
the body
(FDC Act, Section 201)

Devices
An
instrument, apparatus, implement, machine, contrivanc
e, implant, in vitro reagent, or other similar or related
article… which is –
• intended for use in the diagnosis of disease… in
cure, mitigation, treatment, or prevention of disease
• intended to affect the structure of any function of the
body… not achieved through chemical action… or being
metabolized
(FDC Act, Section 201)

Device classifications
Class Description
Class I Least risky, general controls adequate; no clinical
trial needed
Class II Intermediate risk, special controls needed (510k)

Class III Substantial risk devices, pre-market approval
needed (IDE)

Drugs Devices
Chemical/ metabolic action Not metabolized

Distributed systemically Acts locally

May impact metabolism of other
Effects structure
drugs

Larger number of study subjects Smaller number of study subjects
needed to identify side effects needed

Clinical trial needs are based on
Clinical Trial Always Required risk classification of device

Determining the Need for a Clinical
Trial
• In situations of a drug, a clinical trial will always be
required
• However, not all devices will need to undergo a clinical
trial
• The determination of whether or not a device clinical
trial is required is based on a risk stratification

Trial
Drugs Devices

All Drugs require Assess Risk
Clinical Trials Classification

21 CFR 312 Intermediate Risk Substantial Risk
“IND”

Clinical trial MAY be Clinical Trial
required Required

Trial
Devices

Assess Risk
Classification

Intermediate Risk Substantial Risk

Clinical trial MAY be Clinical Trial
required Required

Trial
Risk Stratification
Class Description Risk Classification
Class I Least risky, general controls Minima Intermediat Substantial

}
adequate; no clinical trial needed l Risk e Risk Risk
Class II Intermediate risk, special controls
needed (510k)

Class III Substantial risk devices, pre-market No MAY REQUIRES
approval needed (IDE) Clinical Require Clinical
Trial Clinical Trial
Required Trial

Trial
Risk Stratification
Devices
Drugs

Assess Risk
Classification
All Drugs require
Clinical Trials

Intermediate Risk Substantial Risk

21 CFR 312
“IND”
Clinical trial MAY Clinical Trial
be required Required

Trial
Risk Stratification
Drugs

All Drugs require *Clinical Trials Always
Clinical Trials
Required for New Drugs*

21 CFR 312
“IND”

Clinical Trials
Drugs
Phase Purpose
Phase I Normal healthy volunteers
Determine metabolism and pharmacologic actions
Aim= safety and tolerance
Phase II Patients with the disease or condition
Small Sample
Aim= safety and effectiveness
Phase III Patients with the disease or condition
LARGER population
Aim= safety and effectiveness
Phase IV Post approval studies
Obtain additional information regarding risks, benefits, and
optimal use

Clinical Trials
Devices
Study Purpose
Although there are “phases” in device research, they are not as delineated as
drugs
Pilot May conduct pilot study (strategic decision or FDA request)
Single-center or small number of multi-center sites
Small number of subjects
Safety and tolerance
Pivotal Larger number of subjects
Larger number of sites
Safety and effectiveness
Continued During PMA review of pivotal data, the FDA may grant
Access continued use of the device and allow more subjects to be
enrolled
Post Market Strategic decision or FDA’s request
Method to collect long-term data

Clinical Trials
Drugs and Devices
Feature Drug Device
Rate of technology change Low High
Influence of physician technique Low High
Population size Large Small
Able to visualize performance Low High
Ability to blind treatments Easy Difficult
Use of randomization High Low
Phases Clear Less Clear
(pilot/pivot
al)

Regulatory Overview
What you need to know
21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs;
AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR
Sponsor Good
Internal Requirements CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB
SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 Clinical
Policies
SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFRPractice CFR 11; 21 CFR 50; 21 CFR 812; 21
812; 21
CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; 21 CFR 812; 21 CFR 11; 21
CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR
812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS;
FDA
PROTOCOL; 21 CFR 812; IRB CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB Regulations
21 SOPs; SPONSOR SOPs; SITE
SOPs; AGREEMENTS; Requirements 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR
PROTOCOL; Research
CRO/
54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21
Monitor Sponsor Site
CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR
812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS;
PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB
SOPs; SPONSOR SOPs; NIH SOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs;
SITE ICH
SPONSOR SOPs; SITEGuidelinesAGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR
SOPs; Guidelines
56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21
CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR
11; 21 CFR 50; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 21
CFR 56; ICH; IRB SOPs; SPONSORISO14155SITE SOPs;Investigator
SOPs; Protocol
AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;
Requirements
SPONSOR AND SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;IRB SOPs; It’s Complicated!
Agreements

Regulatory Overview
Our Focus

FDA
Regulations

CRO/ Research
Monitor Sponsor Site

• Investigator(s)
• Research Coordinator(s)
• Other Research Administration
• Institutional Review Board (IRBs)

Regulatory Overview
Code of Federal Regulations

• Requirements for conducting clinical studies

• Outlines responsibilities of the
sponsors, investigators, and IRBs for conducting
trials involving human subjects

Regulatory Overview

Titles

Chapters

Parts

Sections Subparts

Paragraphs

Regulatory Overview

Title: CRF Title 21

Chapter: Food and Drugs

Part: 50 Protection of Human Subjects

Subpart: B Informed Consent of Human Subjects

Section: (a) – Basic Elements of Informed Consent

Section Paragraph: (1) Statement that the study
involves research…

Regulatory Overview
Title: CRF Title 21

Chapter: Food and Drugs

Part: 312 Drugs
Part: 812 Devices
Part: 50 Protection of Human Subjects
Part: 56 Institutional Review Boards (IRBs)
Part: 54 Financial Disclosures
Part: 11 Electronic Records/Electronic
Signatures

Fill in the blanks….
Regarding record maintenance, an investigator must
maintain accurate, complete and current
records, including:

21 CFR 812.140 (1)
All _____________ with another
____________, an _______, the
sponsor, a monitor, or ______, including
required ________________.

Regulatory Overview
Global Perspective
• ISO 14155 has been designed for medical devices

• ICH GCP has origins in the pharmaceutical industry

• ISO 14115 and ICH GCP complement one another
as they are based on the same principles:
– Patient protection
– Documentations
– Risk-benefit assessments
– Ensuring data validity

Regulations
• Regulations that drugs and devices have in
common:
– 21 CFR 11 (electronic records)
– 21 CFR 50 (protection of human subjects)
– 21 CFR 54 (financial disclosure)
– 21 CFR 56 (institutional review board)

Regulations
• Within 21 CFR 312 and 21 CFR 812 are many
similarities:
– Submit to FDA before beginning an investigation
– Update annually
– Amendments required when changes are made
– Promotion and charging for the product
– Labeling
– Waivers
– Product accountability

Sponsor Responsibilities
DRUGS DEVICES
•Select qualified investigators •Selecting qualified investigators
•Provide info to investigators •Provide info to investigators
•Ensure proper monitoring •Ensure proper monitoring
•Ensure trial is conducted in •Ensure trial is conducted in
accordance with the general
investigational plan and protocols accordance with the general
•Maintain an effective IND with investigational plan, protocol,
respect to the investigations agreement, IRB
•Ensure the FDA and investigators are •Ensure IRB review and approval
promptly informed of significant •Ensure IRB and FDA are promptly
new adverse effects or risks with informed of significant new
respect to the drug information

Sponsor Responsibilities
DRUGS DEVICES
312.56: ….(paraphrased) Ensuring that 812.46: (paraphrased) Ensuring
the investigation(s) is conducted in compliance with signed agreement,
compliance with the investigational plan, investigational plan, applicable FDA
the signed agreement, and the applicable regulations, and IRB requirements....
regulations….

Investigator Responsibilities
DRUGS DEVICES
312.60: ….Ensuring that an investigation 812.110: An investigator shall conduct an
is conducted according to the signed investigation in accordance with the
investigator statement, the signed agreement with the sponsor, the
investigational plan, and applicable investigational plan, this part and other
regulations.... applicable FDA regulations, and any
conditions of approval imposed by an IRB
or FDA.

Trials organized
differently
(defined phases
Sponsor v. pilot/pivotal),
responsibiliti but many of the
es similar same
requirements
apply
Investigator
responsibilitie
s similar

Lots of Similarities!

Differences are in the Details

Agreements

Training

Payments

Adverse Events

Agreements

In both drug studies and device studies, the FDA
requires that the investigator comply with the
agreements (21 CFR 312.56 and 21 CFR
812.46), however the agreements are not
identical.

Agreements - Drugs
• The FDA Form 1572 is the
agreement mandated by the
FDA to be completed by all
investigators involved in a drug
trial.
• The agreement describes an
investigator’s qualifications
and specifies his or her
commitment to adhering to
applicable FDA regulations.

Agreements - Drugs
Read the SMALL PRINT of the
1572
Supervise
Maintain Records
Adhere to protocol
Learn investigator
brochure
Let FDA inspect

rePort adverse events
Retain records
Inform subjects
Notify IRB
Read the SMALL PRINT of the 1572, The Essential GCP Document;
http://www.wlap.org/filearchive/cacr/CACR_CRE_ 2.ppt#256,1,Read
the SMALL PRINT of the 1572 staff
Train

Agreements - Drugs
Read the SMALL PRINT of the
1572
Supervise
Maintain Records
Adhere to protocol
Learn investigator
brochure
Let FDA inspect

rePort adverse events
Retain records
Inform subjects
Notify IRB
Read the SMALL PRINT of the 1572, The Essential GCP Document;
Train staff
http://www.wlap.org/filearchive/cacr/CACR_CRE_ 2.ppt#256,1,Read
the SMALL PRINT of the 1572

Agreements - Devices
• No standard format or specific form required
• Direction provided as to what should be included in
the agreements (21 CFR 812.43)
– Investigator qualifications
– Commitment to conduct the study in accordance with
regulations
– Commitment to supervise device use
– Statement regarding involvement in research that was
terminated (if applicable)

Training

Training should be approached differently when
beginning a drug study versus beginning a
device study.

Training
Drugs
• Training on dispensing of product not likely to be needed
• Burden of responsibility to comply with drug regimen lies with
patient/patient’s caregiver
• A sponsor shall select only investigators qualified by training and
experience as appropriate experts to investigate the drug. 21 CFR
312.53
Devices
• Training could be significant and might require the assistance of
engineers, product development, nurses, other physicians, etc.
• Influence of physician technique can be very high depending on
the complexity of device study
• A sponsor shall select investigators qualified by training and
experience to investigate the device. 21 CFR 812.43

Payments

Product reimbursement varies quite a bit
from drugs to devices.

Payments
• Drugs are often provided free of charge to
clinical sites and patients in clinical trials

• Devices expensive to produce

• Having to provide it free could cause a
significant barrier to development

• For some studies, investigator could be
charged for the device (then reimbursed by
Medicare or private insurance)
– “Category B Investigational Devices”

Adverse Events

Due to the systemic nature of drugs, all adverse
events will need to be captured and analyzed as
potentially related to the drug. Devices have a local
affect, and the likelihood of an adverse event being
related to the device is easier to determine. For this
reason, not all negative occurrences in a device
study are reportable.

Adverse events
• AE: Adverse Effect
• SAE: Serious Adverse Effect

ADEs
• ADE: Adverse Device Effect
UADEs
AEs • SADE: Serious Adverse
FDA Device Effect
UADEs
SADEs • UADE: Unanticipated
Adverse Device Effect
• FDA UADE: Unanticipated
Adverse Device Effect that is
Source:
also SERIOUS
Michaels, MB, Applied
Clinical Trials, August
2011, pages 36.

Adverse Events
• UADEs- report to Sponsor and IRB no later
than 10 days after learning of the event

Adverse Events
• Immediately conduct investigation
• If UADE presents unreasonable risks to
subjects, sponsor shall terminate all
investigations within 5 working days of making
that decision

Key Points
• Devices have local affect, drugs
systemic
• Follow different regulatory pathways
• Clinical trials very similar in
requirements
Agreements
• Differences lie in the details:
Training
Payments
Adverse Events

“You can fool all of the people some of the time, and
some of the people all of the time, but you cannot
fool all of the people all of the time.”

- Abraham Lincoln

What You Need to Know
21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs;
AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFRSponsor CFR 50; 21 Good 54; 21 CFR 56; ICH; IRB SOPs;
11; 21 CFR
Internal
SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; Requirements 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21
Clinical
Policies
CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;
Practice
21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE
SOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE
SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs;
FDA
SPONSOR SOPs; SITEIRB SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;Regulations 50; 21 CFR 54; 21
21 CFR
Requirements
CRO/ Research
SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21Sponsor21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs;
CFR 11; Site
Monitor
SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21
NIH
SOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE
Guidelines
ICH Guidelines
SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs;
SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21
21 CFR 50; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS;Protocol
ISO14155 PROTOCOL; 21 CFR 812; 21 CFR 21
Investigator Requirements
Agreements
SPONSOR AND SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;IRB SOPs; It’s Complicated!

Adding To The Mix…

Fixed versus

Variable

A decision about regulatory compliance made at one site for
one study may not be the right decision at another site for the
same study or at the same site for another study….

21 CFR 812 - IDEs

• 812.110: An investigator shall conduct an investigation in
accordance with the signed agreement with the
Investigator sponsor, the investigational plan, this part and other
applicable FDA regulations, and any conditions of
approval imposed by an IRB or FDA.

• 812.46: (paraphrased) Ensuring compliance with
Sponsor signed agreement, investigational plan, applicable
FDA regulations, and IRB requirements....

Working through the chaos

Federal Regulations
Agreements
Investigational Plan
Requirements of IRB

Federal Regulations

• Requirements for conducting clinical studies

• Outlines responsibilities of the sponsors,
investigators, and IRBs for conducting trials
involving human subjects

Federal Regulations

FDA Regulations to Know
812
IDEs (Investigational Device Exemptions)
50
Protection of Human Subjects
56
IRBs (Institutional Review Boards)
54
Financial Disclosures
11
Electronic Records/Signatures

Federal Regulations
21 CFR 812 - IDEs

• Describes the procedures for the conduct
of clinical investigations of devices

• Sponsor responsibilities

• Investigator responsibilities

Federal Regulations
21 CFR 812 - IDEs

• 812.110: An investigator shall conduct an investigation in
accordance with the signed agreement with the
Investigator sponsor, the investigational plan, this part and other
applicable FDA regulations, and any conditions of
approval imposed by an IRB or FDA.

• 812.46: (paraphrased) Ensuring compliance with
Sponsor signed agreement, investigational plan, applicable
FDA regulations, and IRB requirements....

Federal Regulations
21 CFR 812 - IDEs
• Overall conduct of a study:
– Labeling
– Promotion
– Selection of Investigators
– Monitoring (securing compliance)
– Record keeping
– IRB approval…..
DOCUMENT IT!

Federal Regulations
21 CFR 50 – Human Subject Protection
• The rights, safety, and well-being of the trial subjects
should prevail over interests of science and society.
• Freely given Informed Consent should be obtained from
every subject prior to clinical trial participation.
• The confidentiality of records that could identify subjects
should be protected, respecting the privacy and
confidentiality

Federal Regulations

• Specifies:
– Consenting procedures
– Elements to include in an informed consent
– Documentation of informed consent
– Exceptions of informed consent
– Safeguards for children/wards

Federal Regulations
• Sponsor obligations:
– Ensure informed consent process at site level is
compliant with regulatory requirements

DOCUMENT IT!

Federal Regulations
21 CFR 56 - IRBs
• IRBs – Institutional Review Boards (Ethics Committees)
Review and approve research studies involving
human subjects

• 21 CFR part 56 contains general standards for the
composition, operation, and responsibility of an IRB
that reviews clinical investigations regulated by the FDA

Federal Regulations
21 CFR 56 - IRBs

An IRB has the authority to:
• Approve research
• Require modifications in research
• Disapprove research
• Require additional elements of informed consent
are provided
• Waive the requirement for a signed informed
consent

Federal Regulations
21 CFR 56 - IRBs

• Sponsor’s obligations:
– Ensure IRB is operating in compliance with 21 CFR 56
– Ensure site is following IRB procedures

DOCUMENT IT!

Federal Regulations
21 CFR 54 – Financial Disclosure
• Protect the integrity and reliability of clinical data

• FDA considers whether adequate steps are taken in the
design, conduct, reporting and analysis of studies to
minimize bias

• The FDA works with the applicant/sponsor to minimize
potential bias

Federal Regulations
Investigator to
Sponsor to FDA
Sponsor
If financial interests raise questions about data integrity
the FDA may:
• Initiate audits of the data from that investigator
• Request further analyses of data
• Request applicant to conduct additional studies
• Refuse the data

Federal Regulations

• Sponsor’s obligations:
• Collect accurate investigator financial information before study
participation (21 CFR 812.43)
• Report COI to FDA at time of application
• Obtain updates throughout the study and for one year after all
study data is submitted

DOCUMENT IT!

Federal Regulations
21 CFR 11 – Electronic Records

• Describes How:
– Electronic records, electronic signatures,
and handwritten signatures executed to
electronic records are considered
trustworthy, reliable, and generally
equivalent to paper records and
handwritten signatures executed on paper.

Federal Regulations
• To ensure the authenticity, integrity and confidentiality of
electronic records, controls include:
– Tracking of data entry with an audit trail (paper or electronic)

– Documented verification of data entry accuracy

– Unique electronic signatures

Federal Regulations

• Sponsor’s obligation:
– Know the requirements of 21 CFR 11
– Ensure site and internal (sponsor) compliance

DOCUMENT IT!

Agreements

• Statement of investigator’s commitment to:
– Conduct the investigation in compliance with FAIR
– Supervise device use
– Obtain informed consent
– Other items as agreed upon with sponsor…

DOCUMENT IT!

• Inclusion / Exclusion
• Required Testing
• Procedural Requirements
• Randomization Processes
• Follow-up Requirements

DOCUMENT IT!

Requirements of IRB

• Informed consent procedures
• Adverse event reporting requirements
• Renewal timelines
• Etc.

Case Study #1
You are monitoring a site when you
notice that an investigator routinely
signs the consent forms days after the
patients sign them. You’re not sure
what to do. The manager of the brand
new research coordinator tells you that
this is no big deal and there is nothing
to address.

She said “It’s not in the regs…..” Is she
right?

Federal Regulations
Agreements
Requirements of IRB
 Could be specified by the IRB

Case Study #2
A monitor notes that all of the IRB approvals
were on file at a site, but some of the
correspondence back and forth regarding the
approvals was missing. The RC refused to
locate the missing documentation.

The monitor insists “It’s in the Regs….” Is the
monitor correct?

Federal Regulations
 FDA requires that all correspondence with an IRB be maintained (21 CFR 812.140)

Agreements
Requirements of IRB

Case Study #3
You have a site that routinely takes case report
forms (CRFs) into the exam room while seeing
patients. While much of the information you
need for the study is included in the patient’s
regular assessment, they write the other data
directly onto the CRF. You think they need a
separate source, but you’re not sure.

You dig into the regulations and find what???

Federal Regulations
Agreements  Could be in an agreement
 Could be in an
Investigational Plan investigational plan
Requirements of IRB

Sandra Maddock Brandy Smith
CEO and President Director of Clinical Monitoring Services

Meet Our Team
John Lehman Mary Lewis
Director of Business Development Clinical Auditor

More Information for You

Download our Whitepapers

Drugs vs. Devices

References
• FDA’s official website:
• www.fda.gov
• GCP Guidances and Information Sheets
• http://www.fda.gov/oc/gcp/guidance.html
• Informed Consent
• A Guide To Informed Consent:
• http://www.fda.gov/oc/ohrt/irbs/informedconsent.html
• Protection of Subjects:
• http://www.fda.gov/cdrh/devadvice/ide/informed_consent.shtml
• Running clinical trials
• http://1.usa.gov/ILt1tc

Sandra Maddock & Brandy Smith BioEnterprise Presentation 9.6.12

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