MODULE 2: CASE VALIDATION

Case validation is the second step in PV workflow after case intake.
It involves checking whether the received safety information qualifies as a valid Individual Case Safety Report (ICSR) according to regulatory requirements.

Regulators such as EMA, FDA, MHRA, PMDA require four essential elements for a case to be considered valid. The validation step ensures these elements are present and confirms that the case can move to processing and reporting.

Four Minimum Criteria for a valid ICSR

A report is considered valid only if it contains all four elements:

1. Identifiable Reporter

Someone who provided the information must be identifiable.
This includes:

  • Name (even initials acceptable)
  • Contact details (email / phone / address)
  • Qualification (HCP or non-HCP)

Examples of valid reporters:

  • Dr. Rohan (HCP) reporting a side effect through email
  • Patient’s relative calling a helpline
  • Pharmacist reporting a suspected ADR through a portal

2. Identifiable Patient

The patient must be identifiable by at least one descriptor:

  • Age or age group
  • Gender
  • Initials
  • Patient ID number
  • Date of birth
  • Other unique identifiers (but NOT exact address due to privacy)

Example:

  • “55-year-old female treated for hypertension.”
  • “Male infant, 3 months old.”
  • “Patient ID: P12456, M/45 yrs.”

3. Suspect Product

Any drug/medicine/biologic/vaccine suspected to have caused the reaction.
Minimum details needed:

  • Brand name OR generic name
  • Dose, route, indication (if available but not mandatory for validity)
  • If multiple drugs are given, suspect drug must be clearly identifiable

Example:

  • Atorvastatin 20 mg (suspect)
  • COVID-19 Vaccine (suspect)

4. Adverse Event (Reaction)

At least one clinical description of an AE or a change in medical condition after drug exposure.

  • Medical terminology not necessary; lay language is acceptable.
  • Must indicate harm or negative outcome.

Example:

  • “Patient developed severe muscle pain after starting Atorvastatin.”
  • “High fever and chills after vaccination.”
  • “Rash and itching within 2 hours of dose.”

WHY IS CASE VALIDATION IMPORTANT?

·         Ensures compliance with global PV regulations

·         Prevents processing of incomplete or non-reportable cases

·         Helps meet strict reporting timelines (15-day or 7-day expedited reporting)

·         Maintains data quality for signal detection & risk assessment

Note: If any of the four criteria are missing → case is considered INVALID and is kept as Non-Valid Case or Non-Case, documented for record but not processed as ICSR.

VALIDATION WORKFLOW

Step 1: Check for Completeness

The PSA checks if all 4 minimum criteria are present:

  • Reporter? ✔️
  • Patient? ✔️
  • Suspect Drug? ✔️
  • Adverse Event? ✔️

If YES → proceed to validation.
If NO → mark as "Non-valid" and follow internal process (e.g., outreach for missing information).

Step 2: Verify Reporter Identity

  • Ensure the reporter is real (not anonymous).
  • If unclear, PSA may contact reporter for clarification.

Example:
Email received without name → PSA sends follow-up:
“Could you please confirm your name and relationship to the patient?”

Step 3: Confirm Patient Identifiability

PSA ensures that the patient details allow distinguishing this patient from others.

Correct example:
“40-year-old male with diabetes.”

Not acceptable:
“Someone got sick after taking the drug.”

Step 4: Verify Suspect Drug Details

PSA checks:

  • Was the drug taken?
  • Was the drug suspected to cause the event?
  • Is this drug part of the company’s product list?

Step 5: Confirm the Adverse Event

  • The description must indicate harm, disability, abnormal test, or symptom.
  • If unclear (“patient felt something unusual”), PSA requests more information.

Step 6: Determine Seriousness

Once valid, seriousness is assessed based on:

  • Death
  • Hospitalization
  • Life-threatening event
  • Disability
  • Congenital anomaly
  • Medically important event (MIE)

Seriousness determines timelines:

  • Serious cases → 7 or 15-day reporting
  • Non-serious cases → Periodic reporting

Step 7: Date of Awareness

Regulatory clock starts from:

  • The date company FIRST becomes aware of the valid case

This determines the reporting deadline.

Step 8: Documentation & Forwarding

After successful validation:

  • Case is assigned a case number
  • Entered into the safety database
  • Forwarded to the Case Processor