Protocol Understanding_ Clinical Data Management_KatalystHLS

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Protocol Understanding
2/23/2017
Clinical Data Management (CDM)
Katalyst Healthcares & Life Sciences

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• The protocol contains a study plan on which the clinical trial is based.
• Protocol is designed in such a way that it safeguards the health of the participants (while limiting their
financial liability) and also answer specific research questions
• Protocol lays out who, what, why, when, where, how about the clinical trial
• It safeguards clinical trial integrity
Protocol Understanding: Overview
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After completing this chapter you will be able to:
– Understand protocol document
– Understand the contents of a protocol
– Understand the importance of protocol in clinical trials
Objectives:
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• Protocol is a set of rules. Consider that you are driving a car. You have to follow some set of
rules while you are driving. Why are traffic rules required? These traffic rules ensures that
the transportation occurs in smooth and safe way. Similarly in Clinical trials, the protocols
were set up so that the transportation of clinical data across study teams is smooth and safe
• CDISC is creating a standard called the Protocol Representation Model(PRM), which identifies,
defines and describes over 300 common protocol elements and maps those elements to
elements within the BRIDG model. The PRM model is intended as a standard to be used in
designing a study, selecting investigative sites, developing data collection tools, and describing
an analysis plan and study procedures
Do You Know:
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• Amending the protocol immediately after an issue is discovered contributes significantly to
patient safety and overall success of the study
• The following practices should be followed during the design of electronic CRFs:
– The protocol should determine what data should be collected on the CRF
– All data must be collected on the CRF if specified in the protocol
Do You Know:
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• A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical
considerations, and organization of a clinical trial.
- ICH-GCP Guidelines
Protocol Definition:
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• The protocol gives the background and reason the trial is being conducted
• The protocol contains a study plan on which the clinical trial is based. The plan is designed to safeguard
the health of the participants (while limiting their financial liability) as well as answer specific research
questions
• The protocol describes, among other things, what types of people may participate in the trial; the
schedule of tests, procedures, medications, and dosages; and the length of the study
• While in a clinical trial, study participants are seen regularly by the research staff (usually medical doctors
and/or nurses) to monitor their health and to determine the safety and effectiveness of the treatment(s)
they are receiving
Protocol Overview:
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Protocol - Cover Page:
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Protocol Title: A randomized double blind placebo controlled study to investigate the safety of XYZ in healthy adult volunteers
Protocol Number: ABCD0001
Protocol Date: 10 October 2011
Study Phase: I
Project Leader: Jill J Jack
Protocol Author(s): A Fernandes PhD
B Neil PhD
C Frank PhD
Confidentiality Agreement
INVESTIGATOR: A Fernandes
TT Hospital
1st Floor, Ward 1A,
Delhi, India
SPONSOR: ABCL Ltd
The International Centre
Kensington SEZ,
PO Box X11, Mumbai, India
This document is a confidential communication of ABCL Ltd. Acceptance of this document constitutes the
agreement by the recipient that no unpublished information contained within will be published or disclosed
without prior written approval, except that this document may be disclosed to the appropriate Ethics Committee
and Regulatory Authority under the condition that they are requested to keep it confidential

Protocol Content
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1. Background:
• Name and/or identity (i.e. chemical composition) of the investigational drug product(s) and the disease or
condition for which the investigational drug product(s) is (are) being evaluated
• Current status of the disease or condition for which the investigational drug(s) is (are) being evaluated; to
include current problems or deficiencies that warrant an evaluation of the investigational drug
2. Rationale:
• Reason(s) why investigational drug(s) will be safe and effective for the clinical indication
• Description of, and justification for, the proposed route of administration, dosage, dosage regimen, and
duration of dosing of the investigational drug(s)
• Nature of the individuals (e.g., age range, sex, disease state or underlying condition) who will be included in
the proposed clinical evaluation of the investigational drug(s)
• If the investigational drug(s) has (have) been withdrawn from research or marketing in any country for any
reason related to its safety or effectiveness
1. Introduction:
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2. Clinical Study Objectives:
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This section includes:
1. Primary objective:
• Address the primary objective and specific aim(s) of the proposed clinical evaluation of the investigational drug(s)
• Example: To lower the blood glucose level by 20 units
2. Secondary objectives:
• Address, if applicable, secondary objective(s) and specific aim(s) of the proposed clinical evaluation of
the investigational drug(s)
• Example: To improve the quality of life
3. Endpoints: These are outcome measures used to address the objectives of a clinical trial.
• The primary endpoint is the most important outcome and is used to assess the primary objective of a trial
• Example: The variable used to compare the effect difference of two treatment groups).

• The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial
design. This includes:
1. A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during
the trial
2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel
design) and a schematic diagram of trial design, procedures and stages
3. A description of the measures taken to minimize/avoid bias, including:(a) Randomization (b) Blinding
4. A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s).
Also include a description of the dosage form, packaging, and labeling of the investigational product(s).
5. The expected duration of subject participation, and a description of the sequence and duration of all trial
periods, including follow-up, if any
3. Study Design:
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6. A description of the “stopping rules” or “discontinuation
criteria” for individual subjects, parts of trial and entire trial
7. Accountability procedures for the investigational product(s),
including the placebo(s) and comparator(s), if any
8. Maintenance of trial treatment randomization codes and
procedures for breaking codes
9. The identification of any data to be recorded directly on the
CRFs (i.e. no prior written or electronic record of data), and
to be considered to be source data
3. Study Design contd..
14 Katalyst Healthcares & Life Sciences

1. Subject inclusion criteria
Inclusion criteria are characteristics that the prospective subjects must have if they are to be included
in the study
Example:
1. Study subjects must meet age (in years) and gender (men and women) criteria of the study protocol.
2. Study subjects must meet disease criteria as specified by the study protocol.
2. Subject exclusion criteria
Exclusion criteria are those characteristics that disqualify prospective subjects from inclusion in the
study.
Example:
1. Study subjects must not have a medical history of sensitivity, intolerance, or toxicity to the
investigational product, or agents similar to the investigational product.
2. Study subjects must not have donated blood two months prior to study entry, and must not donate
blood after study entry until at least 30 days after the study subject has completed the study.
4. Subject Selection:

3. Subject withdrawal criteria
(i.e. terminating investigational product treatment/trial treatment) and procedures specifying:
a. When and how to withdraw subjects from the trial/ investigational product treatment
b. The type and timing of the data to be collected for withdrawn subjects
c. Whether and how subjects are to be replaced
d. The follow-up for subjects withdrawn from investigational product treatment/trial treatment
4. Subject Selection:
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1. The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing
schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up
period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial
2. Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or
during the trial
3. Procedures for monitoring subject compliance
4. Withdrawal of subjects due to non-compliance/ adherence
5. Study drug supplies:
 Formulation and packaging
 Preparing and dispensing
 Drug administration
6. Study drug storage and accountability
7. Description of Concomitant Medications and Rescue Medications.
5. Study Drug(s):

1. Screening procedures :
Description of the procedures performed at subject screening to verify subject eligibility for study
participation
2. Study drug procedures :
Description of the procedures performed for, and in association with, the administration of the study
drug(s)
3. Follow-up procedures (only if follow-up procedures will be performed)
 Description of follow-up procedures that will be performed after the subject completes the study drug
administration procedures
 Schedule of activities (Study Table)
 A table that summarizes the clinical protocol procedures; to include the procedures that will be performed at
screening, during the study drug administration, and at follow-up (if applicable) to the study drug administration
6. Research Study Procedures:

Assessment of Safety :
1. Specification of safety parameters
2. The methods and timing for assessing, recording, and analyzing safety
parameters
3. Procedures for eliciting reports of and for recording and reporting
adverse event and inter-current illnesses
4. The type and duration of the follow-up of subjects after adverse
events
7. Safety and Efficacy Assessments:
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Assessment of Efficacy :
1. Specification of the efficacy parameters
2. Methods and timing for assessing, recording, and analyzing of efficacy parameters
7. Safety and Efficacy Assessments contd..
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1. Adverse event definitions
2. Recording/Reporting requirements :
 Eliciting adverse event information
 Recording requirements
3. Reporting of adverse reactions :
 Reporting of adverse reactions to the FDA
 Reporting adverse events to the responsible IRB
4. Withdrawal of subjects due to adverse events
8. Adverse Event Reporting:
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1. A description of the statistical methods to be employed, including timing of any planned interim
analysis
2. The number of subjects planned to be enrolled. In multicenter trials, the numbers of enrolled subjects
projected for each trial site should be specified.
3. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and
clinical justification
4. The level of significance to be used
5. Criteria for the termination of the trial
6. Procedure for accounting for missing, unused, and spurious data
7. Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the
original statistical plan should be described and justified in protocol and/or in the final report, as
appropriate)
8. The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed subjects,
all eligible subjects, evaluable subjects)
9. Statistical Methods/Data Analysis:
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Description of nature and timing of the quality control/quality assurance reviews
(i.e., independent of the previously described monitoring activities) that will be undertaken by the Sponsor-
Investigator to ensure appropriate conduct of the clinical research study and quality and completeness of the
accrued study data. I.e., describe the data and safety monitoring plan for the proposed clinical research
study.
10. Quality Control and Quality Assurance:
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1. Data recording/Case Report Forms : A Case Report Form (CRF) should be completed for each subject
enrolled into the clinical study. The Sponsor-Investigator will review, approve and sign/date each
completed CRF; the Sponsor-Investigator’s signature serving as attestation of the Sponsor-
Investigator’s responsibility for ensuring that all clinical and laboratory data entered on the CRF are
complete, accurate and authentic.
2. Record maintenance and retention : The Sponsor-Investigator will maintain records in accordance
with Good Clinical Practice guidelines.
11. Data Handling and Record-Keeping:
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1. Institutional Review Board (IRB) approval
2. Ethical and scientific conduct of the clinical research study
3. Subject informed consent
12. Ethics:
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• Discontinuation of individual research subjects : Addresses any discontinuation criteria or “stopping
rules” for individual research subjects that were not addressed previously under section 5.1.1
(Withdrawal of subjects due to non-compliance/adherence) or section 8.4 (Withdrawal of subjects due to
adverse events) of the clinical protocol.
• Sponsor-Investigator discontinuation of the clinical research study : Describes the discontinuation
criteria or “stopping rules” for parts of the clinical research study, if applicable, or for the entire clinical
research study.
13. Study Discontinuation Criteria:
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• Lets see how does a protocol look like :
Lets discuss:
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1. Define Protocol?
2. Which section of protocol describes procedures for monitoring subject compliance ?
3. Fill in the blank: The Sponsor-Investigator will maintain records in accordance with ________________
4. Procedures for reporting any deviation(s) from the original statistical plan described and justified in
__________and/or in the final report, as appropriate)
Test Your Understanding:
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In this session the following topics were covered:
• Introduction to Clinical study protocol
• Contents of a protocol
• Importance of protocol in clinical trials
Summary:
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You have successfully completed -
Protocol Understanding
Summary:
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Thank You
&
Questions
Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com

Protocol Understanding_ Clinical Data Management_KatalystHLS

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