DH308: NIRMAL PUNJABI

DH 308 – Class 8
27th January 2023

Clinical Data
Management
- Nirmal Punjabi, Ph.D.

Welcome to the course. We will start at 11:05 am.

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Today’s Agenda (Class 8)

• Revisit Class 7 Class 8:
• Clinical Data Planning • Clinical Data Management
• Budget
• Clinical Data Planning
• Major Heads
• Regulations
• Ethics
• Historical Background
• Standards
• GCP
• Regulations • Study Startup
• International
• HIPAA18
• India Specific

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Clinical Data
Planning
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Clinical Data Planning

Ethics

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Good clinical research practice (GCP) ….

• Ethics:
• Ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP
and the applicable regulatory requirement(s).

• Trial risk vs trial benefit:

• A trial should be initiated and continued only if the anticipated benefits justify the risks.

• Trial participants:
• The rights, safety, and well-being of the trial subjects should prevail over interests of science and society.

• Information on the Medicinal Product:

• The available non-clinical and clinical information on an Investigational Product should be adequate to
support the proposed clinical trial.

• Good quality trials:

• Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

• Compliance with the study protocol:

• A trial should be conducted in compliance with the protocol that has received prior institutional review
board (IRB)/independent ethics committee (IEC) approval/favorable opinion.

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Image Reference: ICH-GCP guidelines, WHO GCP guidelines
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Good clinical research practice (GCP) …

• Medical decisions:
• The medical care given to, and medical decisions made on behalf of, subjects should always be the
responsibility of a qualified physician or, when appropriate, of a qualified dentist.
• Trial staff:
• Each individual involved in conducting a trial should be qualified by education, training, and experience
to perform his or her respective task(s).
• Informed consent:
• Freely given informed consent should be obtained from every subject prior to clinical trial participation.
• Clinical trial data:
• All clinical trial information should be recorded, handled, and stored in a way that allows its accurate
reporting, interpretation and verification.
• Confidentiality:
• The confidentiality of records that could identify subjects should be protected, respecting the privacy
and confidentiality rules in accordance with the applicable regulatory requirement(s).
• Good Manufacturing Practice:
• Investigational products should be manufactured, handled, and stored in accordance with applicable
good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
• Quality assurance:
• Systems with procedures that assure the quality of every aspect of the trial should be implemented.

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Image Reference: ICH-GCP guidelines, WHO GCP guidelines
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Clinical Data Planning

Regulations

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Regulations
• First step: Institutional Review Board / Institutional Ethics Committee

• International
• Health Insurance and Portability Act (HIPAA)
• Privacy
• Security
• Federal Information Security Management Act (FISMA)
• Information security; US government agencies and their contractors
• General Data Protection Regulation (GDPR)

• The International Council for Harmonisation of Technical Requirements for

Pharmaceuticals for Human Use (ICH)
• MedDRA
• 21 CFR (Code of Federal Regulations), Part 11
• Electronics Record; Computer systems used in Clinical Trials
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Regulations (India Specific)

• Digital Information Security in Healthcare Act ("DISHA“)
• Electronic health data • PHI
1. Name
• Privacy
2. Address
• Confidentiality 3. Date of Birth
• Security 4. Telephone Number
5. Email Address
• Standardization
6. Password
7. Financial information such as bank account or credit card or debit
• Coverage card or other payment instrument details
8. Physical, physiological and mental health condition
• Ownership of data 9. Sexual orientation

• Patient Consent 10. Medical records and history

• Purpose for access to data
• Storing of Digital data
11. Biometric Information
12. Vehicle number
13. Any government number, including Aadhar, Voter’s Identity,
Permanent Account Number (‘PAN’), Passport, Ration Card, Below
Poverty Line (‘BPL’).
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Regulations (India Specific)

• Digital Information Security in Healthcare Act ("DISHA“)

• Ambiguity/Cons
• No clarity about implementation on a large scale

• Use of unidentified data for clinical research requires consent of individuals.

• Discontinued

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Regulations (India Specific)

• The Drugs and Cosmetics Act 1940 & Rules 1945

• Data Protection Framework on Digital Information Privacy, Security &

Confidentiality’ Act
• Ministry of Electronics & Information Technology (MeitY)

• The Digital Personal Data Protection Bill, 2022

• Ayushman Bharat Digital Mission

• Health Data Management Policy
• Health Data Retention Policy (In early stages)

• New Drug and Clinical Trials Rule, 2022

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Regulations (India Specific): Regarding Saving

Data
• The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations,
2002
• “every physician shall maintain the medical records pertaining to his / her indoor patients for
a period of 3 years from the date of commencement of the treatment in a standard proforma
laid down by the Medical Council of India”.

• The Clinical Establishments (Registration and Regulation) Draft Rules, 2010

• Medical Records should be retained for 3 to 5 years

• Directorate General of Health Services for Central Government Hospitals in 2014

• Indoor patient medical record: 10 years
• OPD: 3 years

• The Pre-Conception Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection)

Act, 1994,
• Documents : 2 years

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Regulations (India Specific): Regarding Saving

Data
• The Personal Data Protection Bill, 2019
• Data can be stored only for as long as it is necessary to satisfy the purpose for
which the data has been recorded by the entity.

• The Personal Data Protection Bill, 2022

• Deemed consent

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Regulatory requirement
• Where to check?
• Clinical Trials Registry- India (CTRI)
• Central Drugs Standard Control Organisation(CDSCO)

• Do multinational companies having FDA approval for drugs needs to clinical trial in India?
• Companies will have to do bridging trials in India.

• Exceptions:
• For covid19 vaccines approved by US FDA, UK MHRA, EMA, PMDA Japan & WHO EUL:
As, per government circular dated 1st June 2021 has waived the bridging trials for
approved vaccines.
• But other checks like assessment of testing of vaccines and observation of 100 subjects.

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Regulatory requirement

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Clinical Data Planning

Standards

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Needs for standards

• Same symptoms are referred differently
• Example: Fever OR Pyrexia

• Different disease can have common symptoms

• Example: CT scan images of lungs
• Pneumonia for Covid19 OR tuberculosis OR non-covid pneumonia

Reference: https://www.himss.org/resources/interoperability-healthcare 17
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Data Interoperability
• Foundational
• Establishes the inter-connectivity requirements needed for one system or application to
securely communicate data to and receive data from another
• Structural
• Defines the format, syntax and organization of data exchange including at the data field level
for interpretation
• Semantic
• Supports common underlying models and codification of the data including the use of data
elements with standardized definitions from publicly available value sets and coding
vocabularies, providing shared understanding and meaning to the user
• Organizational
• Includes governance, policy, social, legal and organizational considerations to facilitate the
secure, seamless and timely communication and use of data both within and between
organizations, entities and individuals. These components enable shared consent, trust and
integrated end-user processes and workflows

Reference: https://www.himss.org/resources/interoperability-healthcare 18
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Standard Classifications
• WHO Family of Classifications
• International Statistical Classification of Diseases and Related Health
Problems (ICD),
• Hierarchical
• ICD10, ICD11
• Example: Health condition of trial participant is coded as ICD-10 in CTRI, India
• International Classification of Functioning, Disability and Health (ICF),
• International Classification of Health Interventions (ICHI).

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WHO ICD classifications (Example)

Image Reference: https://www.who.int/standards/classifications/classification-of-diseases/emergency-use-icd-codes-for-covid-19-disease-outbreak 20

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Standard Classifications
• Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT)
• Health/Clinical Terms
• Collection of names and words

• Polyhierarchical knowledge representation

• Organised in a structured and logically consistent manner

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SNOMED CT Content
• Disease and deformity – scar
Clinical • Symptoms – difficulty breathing
Findings • Social – finding of walking aid use
• Examination findings – tachycardia

• Forces – pressure change

Causes of • Events – road traffic accident
Disease • Organisms – herpes simplex virus

• Laboratory
• Therapy
Procedures • Clinical Investigation
• Surgical procedure
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SNOMED CT Content
• Normal – knee joint
Anatomy • Abnormal – ganglion cyst
• Lesions – bony callus

• Vital signs – blood pressure

Observations • Body product observable – colour of urine
• Values - present

• Drugs – paracetamol
Products • Substances – latex
• Devices – bedpan
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A Concept

Codes and descriptions

Relationships

Qualifiers
Is a Attributes
& values
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A Concept in SNOMED CT

Preferred Term: Heart Disease

Synonym: Cardiopathy
Heart disease (disorder)
Synonym: Disorder of Heart 56265001
Synonym: Morbus Cordis
Synonym: Cardiac Disorder
Synonym: Cardiac Diseases Relationships
Synonym: Heart Diseases

Is a cardiac Finding site Severity

finding heart Episodicity
Is a disorder of structure Courses
mediastinum
Is a disorder of
cardiovascular
system
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Standard Classifications
• Logical Observation Identifiers Names and Codes (LOINC®)
• Codes for Testing methods in Laboratory

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Standard Classifications
• Health Level Seven (HL7)
• Standard for medical information exchange
• Format for inter-operability
• Combines standard medical terms from SNOMED & LOINC
• Admin & Technical

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Clinical Data Planning

SOP/ Protocol

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Standard Operation Procedure

• “Standard Operating Procedures (SOPs) are detailed, written
instructions which must be followed when performing certain tasks.
They are an essential source for communicating to researchers the
agreed, defined methodology which must be followed to ensure
consistency between researchers and, in multi-centre studies, the
consistency between individual research sites.”
• Helps in compliance with GCP & regulatory requirements

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Standard Operation Procedure

• Sections: • Good Practices:
• Purpose • Self Explanatory
• Definitions • Understand real world
• Abbreviations challenges
• Procedure • Should not be open-
• References ended)
• Document History • Should be able to
(Created, Modified, document changes
Accepted,..)

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