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PV Modules

MODULE 1: CASE INTAKE (INITIAL STEP)

What is Case Intake?

Case Intake is the first step in the Pharmacovigilance (PV) workflow where information about a potential adverse event (AE) is received, captured, and logged into the PV system. This step ensures that every safety-related report reaching the company is identified, documented, and forwarded for validation.

The purpose is to:

  • Identify whether the received information is related to an adverse event
  • Collect all available details from the source
  • Assign a Day 0 (date when the company becomes aware of the AE)
  • Generate a unique case reference number
  • Transfer the case to the Case Validation step

SOURCES OF CASE INTAKE

A case may come from multiple channels such as:

  • Healthcare professionals (HCPs)
  • Patients/caregivers
  • Call centres
  • Market complaints
  • Literature monitoring
  • Clinical trials
  • Social media (Twitter, Facebook, Instagram — if monitored)
  • Company website or mobile app
  • Patient support programs
  • Sales representatives
  • Regulatory authority reports

Minimum Criteria for a Valid Case

A valid ICSR case must have:

  1. Identifiable Patient
  2. Identifiable Reporter
  3. Suspect Product
  4. Adverse Event / Complaint

Note: If any of these four are missing → case is invalid and marked as non-valid.

WHAT A PSA DOES AT CASE INTAKE?

The PSA must:

1.      Identify if the report contains safety information

Does it describe:

  • An adverse event?
  • A product quality issue?
  • A medication error?
  • Lack of efficacy?
  • Misuse/overdose?

2.      Capture all the information exactly as received: No interpretation is done here.

3.      Assign DAY 0: Day 0 = the date when anyone in the company becomes aware of the AE.

4.      Assign a case ID: Case is logged into a safety database like ArisG, Argus, or Veeva.

5.      Forward the case to Case Validation team

EXAMPLE OF CASE INTAKE:

Scenario

A patient calls the company’s medical information helpline to report an issue.

Patient’s Message

“I started taking Metformin 500 mg last week. After two days of starting the medicine, I developed severe stomach pain and loose motions. I stopped the medicine yesterday but I still feel weak.

My name is Anita Sharma. My doctor is Dr. Mehta.”

How the PSA Handles This Case

Step 1: Identify the safety information

The message contains:

  • Suspect drug: Metformin 500 mg
  • Adverse event: Severe stomach pain, loose motions
  • Patient identifier: Name – Anita Sharma
  • Reporter: Patient herself

So, it looks like a potential AE case.

Step 2: Capture the information exactly as provided

PSA records:

  • Reporter name: Anita Sharma
  • Reporter type: Consumer
  • Drug: Metformin 500 mg
  • Event: “Severe stomach pain and loose motions”
  • Start date: “Last week”
  • Onset date: “Two days after starting”
  • Action taken: Stopped medicine yesterday
  • Outcome: Not recovered / ongoing weakness

No interpretation or judgment is added.

Step 3: Assign DAY 0

If the call was received on 20 November 2025, Day 0 = 20 November 2025.

This date will influence reporting timelines later.

Step 4: Create a unique Case ID

Example: CASE-ID: IND-MET-2025-001245

This case will be processed further in the database.

Step 5: Forward the case for Case Validation

The validator will now check whether:

  • It meets the minimum 4 criteria
  • It is serious or non-serious
  • It needs follow-up
  • It needs expedited reporting

CASE INTAKE – KEY POINTS TO REMEMBER

  • No interpretation or medical judgement is added
  • No correction of grammar or text
  • AE must be captured in verbatim
  • Day 0 must be accurate
  • Intake must be completed within strict timelines
  • All information sources must be screened daily