Intentional re-challenge, a practice within clinical data management, is a deliberate and controlled re-administration of a drug to a patient who has previously experienced an adverse drug reaction or drug-related problem during the course of a clinical trial. This process is undertaken to confirm the causality between the drug and the observed adverse event, gain a deeper understanding of the event's mechanisms, and assess the potential for its recurrence. Clinical data management plays a pivotal role in documenting and tracking these intentional re-challenges, meticulously recording patient information, medical history, dosage regimens, and the nature and severity of the adverse event. The data management process ensures that the re-challenge is conducted in a controlled and ethical manner, with a keen focus on patient safety. This comprehensive data management approach aids in evaluating the drug's safety profile, informing regulatory decisions, and ultimately contributing to the overall pharmacovigilance and risk assessment of the drug under investigation.

1. Welcome
Intentional re-challenge and the clinical data
management of Drug Related problems
MOHAMED SALIH ASLAM
B.PHARM
Student ID -188/092023
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2. CONTENTS
• INTRODUCTION
• STRATEGIES
• IMPORTANCE OF INTENTIONAL RE-CHALLENGE
• CLINICAL DATA MANAGEMENT
• TOOLS FOR CDM
• CDM PROCESS
• LIST OF CDM ACTIVITIES
• CONCLUSION
• REFERENCES
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3. INTRODUCTION
Intentional Re-challenge:
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Rechallenge refers to the re-administration of a medication suspected of causing an
adverse reaction, considering the benefit/risk balance of the medication and
alternative treatments.
Clinical data management involves meticulously gathering, documenting, and analyzing
patient medical history, adverse events, and re-challenges to make informed decisions
about drug safety and patient response, a crucial step in evaluating and managing drug-
related issues.
Clinical data management of Drug Related problems

4. STRATEGIES
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‘Type A’:
Drug interactions are a subtype of Type A adverse reactions, requiring a rechallenge test
based on pharmacological criteria, involving low dose within therapeutic range or high doses
if therapeutic failure occurs.
‘Type B’:
Hypersensitivity reactions require a rechallenge test, often based on immunological or
metabolic criteria, with low doses. Rechallenge is potentially dangerous. The underlying
mechanism is uncertain, and cross hypersensitivity may occur.
‘Type C’:
These reactions often have no suggestive time course and may follow neither
pharmacological nor immunological principles. For example, increased risk of acquiring a
‘natural’ disease (e.g. myocardial infarction, pulmonary embolism), or increased frequency of
a recurrent but transient event (e.g. more frequent migraine or convulsions)

5. IMPORTANCE OF INTENTIONAL RE-CHALLANGE
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Causality
Confirmation
Pharmacov
igilance
Treatment
Decision
Patient
safety
Avoiding
Misdiagnosis
IMPORTANCE
OF
INTENTIONAL
RE-
CHALLANGE

6. CLINICAL DATA MANAGEMENT
Definition
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The process of collecting, scrubbing, and managing subject data in accordance with regulatory
requirements is known as CDM. The primary objective of CDM processes is to provide high-
quality data by keeping the number of errors and missing data as low as possible and gather
maximum data for analysis.
Purpose of CDM
❑ Clinical data management's (CDM) goal is to produce accurate, trustworthy, and
statistically sound data from clinical trials.
❑ CDM ensures the collection, integration, and availability of data at appropriate quality
and cost.
❑ CDM plays an essential role in the data collection phase of clinical research.

7. TOOLS FOR CDM
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✓ Many software tools are available for data management, and these are called
Clinical Data Management Systems (CDMS).
✓ Commonly used CDM tools are
❖ ORACLE CLINICAL
❖ CLINTRIAL
❖ MACRO
❖ RAVE and
❖ eClinical Suite

8. THE CDM PROCESS
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❖ The CDM process is designed to deliver an error-free, valid, and statistically sound database.
To meet this objective, the CDM process starts early, even before the finalization of the study
protocol.

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Review and finalization of study documents
➢ The protocol is reviewed for clarity and consistency, with the CDM team designing a
Case Report Form (CRF) to translate protocol-specific activities into data.
➢ The CRF should be concise, self-explanatory, and user-friendly, with clear data fields
and units.
➢ Filling instructions (CRF Completion Guidelines) should be provided for error-free
data acquisition.

10. LIST OF CDM ACTIVITIES
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Database locking
Medical coding
Discrepancy management
Data validation
Data entry
CRF tracking
Data collection
Database designing

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CRF tracking
Logistic way if it is paper based study. EDC-electronic data capture if it is e-CRF
Data entry
Data entry is a process of entering /transferring data from case report form to clinical data
management system (CDMS)
Database set up and testing
Database setup and testing are always performed in a secure, non -study data environment.
Only when a database has been reviewed and fully tested, will it be set in ‘production’, a
separate environment where only study data will be entered.
Data collection process
Gathering of data in the course of trail from patient medical history, initial adverse event
details, monitoring during re-challenge, and documentation of outcomes

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Discrepancy management
Discrepancy management is a process of cleaning subject data in the
clinical data management system (CDMS), it includes manual checks
and programmed checks.

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Database lock
The database lock for a study is done to ensure no manipulation of study data
during the final analysis
Quality control
Quality should be maintained for overall study by performing quality
checks at intervals for all data points prior to database lock.
Medical coding involves identifying and classifying medical
terminologies in clinical trials using online medical dictionaries.
Knowledge of medical terminology, disease entities, drugs, and
pathological processes is required. Customized dictionaries are also
used by pharmaceutical companies.
Medical coding

14. CONCLUSION
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Intentional re-challenge confirms if a drug caused an adverse
reaction. Following careful steps and data collection ensures
safety and reliable results. This helps diagnose accurately and
decide treatments better. Alongside good data management,
intentional re-challenge guides healthcare professionals by
telling apart real drug reactions from coincidences. This
makes treatment plans personal and boosts patient safety.

15. REFERENCES
▪ Meyboom, R. Intentional Rechallenge and the Clinical Management of
Drug-Related Problems. Drug Saf 36, 163–165 (2013).
▪ https://doi.org/10.1007/s40264-013-0023-0
▪ https://www.clinion.com/insight/clinical-data-management-whatare-
the-key-challenges/
▪ Stephens M. "Deliberate Drug Rechallenge." Human Toxicology.
1983;2(4):573-577. doi:10.1177/096032718300200401
▪ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/
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16. Thank You!
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