1. Introduction to Clinical Protocol
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2. Topics To be Covered What is Protocol Protocol Outline Protocol Design
Study Procedure
Informed Consent process
Subject Confidentially
Data Recording
GCDMP
Data Management Plan
Data Capture
Data Quality Assurance
Data Validation
Query Management Plan
Best Practice for CRF
Statistical Analysis
Data Locking
Appendices / Supplements
Conclusion
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3. Protocol
A protocol is a document that states the reasoning behind and structure of a research project
Protocol also defined as a document that describes the background, rationale, objectives, design, methodology, statistical consideration and organization of trial
The Study protocol can be viewed as a written agreement between the investigator , the participants and the scientific community
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4. Protocol Outline A typical protocol has the following elements:
Title Page
Objectives
Signature Page
Study Design
Background Information and scientific rationale
Study Population
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5. Protocol Design Study Procedure Informed Consent process
Statistical Considerations
Literature References
Subject Confidentiality
Supplements / Appendices
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6. Title Page
Title pages introduce the document, their title, precise number, sponsor and author to the reader
Protocol title, protocol identifying number, and date
Any amendments should also bear the amendment number and date
The protocol number must clearly indicate the version number, whether it is final or draft and date of this version
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7. Continue…Elements Full title should include: Placebo
Summary study design
Indication
Patient population
Medicinal products
Setting (ex: in-patient, outpatient)
Nature of the treatment (ex: treatment, prophylaxis and diagnosis)
Randomized
Double Blind
Multiple Studies
Comparator
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8. Continue…
2. Name and address of the sponsor and monitor. Sponsor names and list of responsibilities with agreed allocations
3. Name and title of the person authorized to sign the protocol and the protocol amendments for the sponsor. Generally, Chief Investigator for multiple center trials or Principal Investigator for single center trials
4. Name, title, address and telephone number of the sponsor medical expert for the trial
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9. Continue…
5. Name and title of the investigator who is responsible for conducting the trial, and the address and telephone numbers of the trial site
6. Name, title , address and telephone number of the qualified physician who is responsible for all trial site related medical decisions
Name and address of the clinical laboratory and other medical and /or technical department and /or institution involved in the trial
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10. Protocol Summary/Synopsis
This summary should be only one to two pages long
It should give the reader sufficient information to understand the rationale for the trial, its objective and the methods that will be used to achieve these objectives
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11. Study Objective/Aims
A clinical trial often has both primary and secondary objective, and these should be identified as such in the protocol
Ideally, no more than 1 or 2 of each should be included in a clinical trial
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12. Signature Page
Signature page of the healthcare professional in the trial including contact details of participating site, sponsor and sponsor medical advisor if not already given above.
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13. Content Page
This helps navigating through the document by large number of different people that will be needed throughout the life of the trial
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14. Study Design A description of the trial design should include:
A description of the design of trial to be conducted
ex: double blind, placebo controlled, parallel design
2) A description of the measure taken to minimize/
avoid bias
A) Randomization
B) Blinding
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15. Continue… A description of the trial treatment and the dosage
and dosage regimen of the IP. Also, include a
description of the dosage form, packaging and
labeling of the IP
4) The expected duration of subject participation , and
description of the sequence and duration of all trial
periods, including follow up any.
5) A description of “stopping rile” or “Discontinuation Criteria”
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16. List of Abbreviation
All abbreviations used should be listed and defined
Accepted international medical abbreviations should be used
Project specific abbreviations should be standardized with each project
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17. Compliance Statement
The protocol should include a trial statement with the protocol, GCP and the applicable regulatory requirements
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18. Background Information
Name and description of the investigational product
A summary of finding from nonclinical studies that potentially have clinical significance and form clinical trials that are relevant to the trial
Summary of the known and potential risks and benefits, if any, to human subjects
Description and justification for the route of administration, dosage, dosage regimen and treatment period
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19. Continue… Description of the population to be studied
In short, the data in this background information should be able to justify the need for this study
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20. Selection and Withdrawal of Subjects
Subject Inclusion Criteria
Subject Exclusion Criteria
Subject Withdrawal Criteria
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21. Treatment of Subjects
The treatment to be administered, including the name of all the products, dose, the dosing schedule, the route/mode of administration and the treatment period
ii) Medication/ treatment permitted and not permitted before and/ or during the trial.
iii) Procedure for monitoring subject compliance
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22. Assessment of Safety Specification of safety parameters
ii) The methods and timing for assessing, recording,
and analyzing safety parameters
iii) Procedure for eliciting reports of and recording and
reporting adverse event and inter current illnesses
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23. Direct Access to Source Data Document
Sponsor ensures that it is specified in the protocol or other written agreement that the investigator will permit trial related monitoring, audits, IEC review, and regulatory inspection by providing direct access to source data/documents
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24. Informed Consent
Defined as: a patient is being given adequate information about a clinical trial; understanding and voluntarily accepting the terms of a clinical trials and agreeing to cooperate in its conduct
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25. The following slides are the key concepts to be considered while designing the protocol, which impact the Clinical Data Management
Data Recording
Data Quality Assurance
Statistical Analysis Plan
The following slides are the key concepts to be considered while designing the protocol, which impact the Clinical Data Management
Data Recording
Indicate how data will be collected. If detailed instructions have been prepared, specify their location (study manual, appendix)
Discuss the use and management of source documents.
Discuss the procedure for correcting errors.
Data Quality Assurance
Describe any procedures for assessing subject compliance
Discuss source document review
Provide GCP references
Statistical Analysis Plan
Statement of the planned sample
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26. Data Handling and Record Keeping
Indicate how data will be collected. If detailed instructions have been prepared, specify their location (study manual, appendix)
Discuss the use and management of source documents
Discuss the procedure for correcting errors
GCDMP
Data Management Plan
Data Capture
CRF
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27. Data Handling and Record Keeping
Good Clinical Data Management Practices
Provides assistance to clinical data managers in their implementation of high quality Clinical Data Management processes
Used as a reference tool for clinical data managers
Review and approval of new medications or medical devices
Clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes
Roles:
Ensure the highest possible degree of integrity in your research.
Ensure that all methods and practices accelerate the timeline from data collection to data analysis and publication
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28. Data Handling and Record Keeping
2. Data Management Plan
Record all the most important information on how data management was carried out for a study
The documents are more accurate when written at the start of the study
Provides a focus for identifying the work to be performed, who will perform the work, and what is to be produced as documentation of the work
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29. Data Handling and Record Keeping
Data Management Plan
Continued…
Touches the elements of the data management process for the study in question
Becomes an approximate table of contents
Used as a source document for internal quality assurance audits
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30. Data Handling and Record Keeping
3. Data Capture
Electronic Data Capture
EDC systems deliver clinical trial data from the investigation sites to the sponsor
Eliminates the need for double-key data entry
Data management planning and implementation are completed even before data entry is initiated
EDC systems are improved for site activities during a clinical trial
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31. Data Handling and Record Keeping
Best Practice for CRF
A tool used to collect pre- defined data from a subject in a clinical trial
Design the CRF along with protocol
Keep questions, prompts and instructions clear and concise
Design the CRF to follow the data flow from the perspective of the person completing it
Avoid referential and redundant data points within the CRF
Design the CRF with the primary safety and efficacy endpoints in mind
Establish and maintain a library of standard forms
Make the CRF available for review at the clinical site prior to approval
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32. Data Quality Assurance
Describe procedures for assessing subject compliance
Discuss source document review
Provide assurance on good clinical practice, quality of data collection and refer to monitor and their role
Data Validation
Query Management
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33. Data Quality Assurance
Data Validation
Important role within the drug development program involving many people, multiple systems, and several data transfers
Automated and manual procedures to detect missing entries, illogical data
Ensures Data accuracy and Completeness
Helps to inform Data Managers about data issues in timely fashion
Once data validation is completed it is time for Data Treatment stage
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34. Data Quality Assurance
Data Validation
Continued…
Factors affecting the quality of data
CRF design
Field Monitoring Guidelines
Source data verification
Missing data/ CRF pages
Data conventions
Electronic laboratory data
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35. Data Quality Assurance
2. Query Management
Performance metrics are tracked routinely and analyzed periodically to ensure maintenance of the highest data management quality standards
All discrepancies are identified automatically by the system that are reviewed by a data manager
These are resolved internally through inspection of the CRF
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36. Data Quality Assurance
Query Management
Continued…
Following actions can be taken based on project specific guidelines
Closing discrepancy per internal connection
Generating a query to the investigator
Creating queries
Sending queries
Tracking queries
Resolving queries
Re-quering
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37. Data Quality Assurance
Query Management
Continued…
Turning a discrepancy into a query
Resolving queries
Applying the Resolution
Quality assurance and control
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38. Statistical Analysis Plan
It is critical to specify in the protocol the precise definition of the primary variable as it will be used in the statistical analysis.
Oversees the processes that group, summarize, analyze, and otherwise present trial data for clinical interpretation
Statement of the planned sample size
Classification of the study variables
Information about the timing and purpose of any planned interim analysis
Handling of missing or non- evaluable data
It is critical to specify in the protocol the precise definition of the primary variable as it will be used in the statistical analysis.
Oversees the processes that group, summarize, analyze, and otherwise present trial data for clinical interpretation
Statement of the planned sample size
Classification of the study variables
Information about the timing and purpose of any planned interim analysis
Handling of missing or non- evaluable data
Data Locking
These processes often include statistical computer programming as well as development of the analysis plan
A description of the statistical methods to be employed, including timing of any planned interim analysis
The number of subjects planned to be enrolled
The level of significance to be used
Criteria for termination of the trial
Procedure for accounting for missing, unused and spurious data
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39. Statistical Analysis Plan
Data Locking
Once the patient’s data has been collected, the study needs to be locked in an expeditious manner
The list involves many steps:
Collecting final data
Resolving outstanding queries
Reconciling against other databases
Performing final QC
After these tasks are done, data manager reviews with the clinical group and the study is considered locked- no data will be changed, from the first patient in through to database lock
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40. Appendices
Based on the protocol, relevant appendices as elaborated should be attached:
Summary of Product characteristics, data sheer for IP
Measurement tools and their validation
Pharmacy information, shelf lives, dispensing procedure
Methods for collecting patient samples, their storage,
dispatch and handling conditions
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41. Continue… Clinical labs and tests
Adverse reaction grading systems for particular safety parameters
Scoring systems of efficiency parameters
Analysis diagram
Declaration of Helsinki
Patients and parent/legal guardian consent form
Subject information sheet for informed consent
Method of recruitment of patients/subjects to the trial
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42. Conclusion
Protocol is a blue print for a study. It contains all the information necessary
Certain Information is required by regulation to be into protocol
The following are the key points that follow Data Management Protocol:
Data Recording
GCDMP
DMP
Data Capture
CRF Practices
Quality Assurance
Data Validation
Query Management
Statistical Analysis
Data Locking
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43. Thank You
For queries or questions, please at
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