This section captures essential details about the Healthcare Professional and product to establish proper identification and interaction context. All fields marked mandatory must be completed to ensure regulatory compliance and accurate record-keeping.
HCP Full Name
Professional Credentials & Degrees
Primary Medical Specialty
Cardiology
Oncology
Neurology
Endocrinology
Rheumatology
Gastroenterology
Infectious Disease
Hematology
Dermatology
Psychiatry
Nephrology
Pulmonology
Other Specialty
Subspecialty (if applicable)
Practice Setting Environment
Academic Medical Center
Tertiary Hospital
Community Hospital
Private Practice
Group Practice
Clinic Setting
Research Institution
Government Hospital
Other Setting
Geographic Region/Location
Professional Registration/License Number
Professional Email Address
Contact Phone Number
Years of Clinical Practice
Has this HCP interacted with our Medical Affairs team in the past 12 months?
Describe previous interaction context and topics discussed:
Product & Indication Details
Product Brand Name | Generic Name/Active Ingredient | Formulation & Strength | Approved Regulatory Indication | Off-Label Use Being Discussed (if applicable) | ||
|---|---|---|---|---|---|---|
A | B | C | D | E | ||
1 | ExampleBrand | exampleumab | IV infusion 100mg | Rheumatoid Arthritis | Systemic Lupus Erythematosus | |
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Interaction Channel
In-Person Meeting
Virtual Video Conference
Phone Call
Scientific Conference
Medical Advisory Board
Email Correspondence
Webinar Q&A
Other Digital Platform
Interaction Date & Time
Interaction Duration
Comprehensive documentation of the clinical inquiry and patient context is essential for medical assessment. Provide detailed yet de-identified patient information to support medical affairs review while maintaining patient privacy standards.
Primary Category of Medical Inquiry
Efficacy & Effectiveness
Safety & Tolerability
Dosing & Administration
Contraindications & Precautions
Drug-Drug Interactions
Use in Special Populations
Mechanism of Action
Clinical Trial Design
Real-World Evidence
Mechanism of Resistance
Other Scientific Topic
Detailed Clinical Scenario & Medical Question
De-Identified Patient Demographics & Baseline Characteristics
Parameter | Value or Range | Clinical Relevance & Notes | ||
|---|---|---|---|---|
A | B | C | ||
1 | Age Range | 45-55 years | Patient in prime working age, compliance concerns | |
2 | Gender | Female | Relevant for pregnancy considerations | |
3 | Weight Range | 70-80 kg | Within normal BMI range | |
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Relevant Medical History & Comorbidities
Prior Treatment History & Previous Therapies
Concomitant Medications & Non-Drug Therapies
Current Treatment Regimen with Product
Specific Patient Outcomes & Clinical Observations
Timeline of Key Clinical Events
Clinical Impact Assessment - Rate the following aspects of this inquiry
Very Low | Low | Moderate | High | Very High | |
|---|---|---|---|---|---|
Medical significance to patient care | |||||
Scientific complexity | |||||
Urgency of response needed | |||||
Potential for clinical practice impact |
This section ensures regulatory compliance by documenting the unsolicited nature of the inquiry and verifying that fair balance was maintained when discussing off-label uses. Complete all fields meticulously as this information may be subject to regulatory inspection.
Was this inquiry completely unsolicited by the MSL or company?
Explain any prior discussion, prompting, or initiation by the MSL that may have stimulated this inquiry:
Specific Off-Label Use or Investigational Context Discussed
Did the MSL provide any information regarding the off-label use?
Describe exactly what information was provided and how it was framed within the context of the unsolicited request:
Fair-Balance Documentation - How were risks, limitations, and approved alternatives presented?
Types of Scientific Materials Referenced or Shared (select all that apply)
Approved Product Information/Prescribing Information
Peer-Reviewed Publication
Clinical Trial Data
Conference Presentation Slides
Medical Affairs Standard Response Letter
Clinical Guidelines
No Materials Used - Verbal Only
Other Scientific Material
Were all shared materials previously reviewed and approved by Medical Affairs?
Provide approval reference number:
Explain the nature of unapproved materials and immediate actions taken:
Did the MSL make any commitments for follow-up actions or additional information?
Detail all commitments made including timelines and specific information to be provided:
Key Literature References or Data Sources Cited During Discussion
Compliance Risk Self-Assessment - Rate each compliance parameter
Clarity of unsolicited nature | |
Fair balance achieved | |
Appropriate scope of information | |
Avoidance of promotional language | |
Documentation completeness |
Patient safety is paramount. This section must be completed for ANY inquiry involving adverse events, side effects, or unexpected outcomes. Timely and accurate reporting is essential for regulatory compliance and patient protection.
Does this inquiry involve a potential Adverse Event (AE) or unexpected side effect?
Detailed AE Description - Include symptoms, diagnosis, clinical signs, and evolution
Is this a serious adverse event based on regulatory criteria?
Seriousness Criteria Met (select all applicable)
Results in death
Life-threatening condition
Requires inpatient hospitalization
Prolongs existing hospitalization
Results in persistent disability
Results in congenital anomaly
Requires intervention to prevent permanent impairment
Other medically important condition
Causality Assessment - Relationship to Product
Related
Possibly Related
Probably Not Related
Not Related
Unassessable/Unclassifiable
AE Onset Date
Treatment Duration Before AE Onset
Relevant Medical History & Risk Factors
Action Taken with Product After AE
Dose not changed
Dose reduced
Dose increased
Drug interrupted
Drug withdrawn
Not applicable
Unknown
Outcome of the Adverse Event
Recovered/Resolved
Recovering/Resolving
Not Recovered/Not Resolved
Recovered with Sequelae
Fatal
Unknown
Reporter Information for AE
Reporter Name | Relationship to Patient | Contact Information | Is reporter a Healthcare Professional? | ||
|---|---|---|---|---|---|
A | B | C | D | ||
1 | Dr. Smith | Treating Physician | dr.smith@clinic.org | Yes | |
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Was this AE reported to Company Pharmacovigilance within 24 hours?
Date & Time Reported to PV
Explain reason for delayed reporting and immediate corrective actions:
Additional Safety Observations or Patterns Noted
This final section ensures appropriate oversight and governance of medical inquiries. All off-label discussions and AE reports require director-level review and approval before closure.
MSL Initial Risk Assessment - Overall Risk Level
MSL Summary & Recommendation
Does this inquiry pass initial compliance and policy check?
Describe compliance concerns and immediate actions taken:
Is Medical Affairs Director review and approval required?
Priority Level for Director Review
Routine (within 5 business days)
High Priority (within 48 hours)
Urgent (within 24 hours)
Immediate (same day)
Date Submitted for Director Review
Director Approval Status
Pending Review
Approved - No Further Action
Approved - With Conditions
Rejected - Requires Revision
Escalated to Safety Committee
Escalated to Legal/Compliance
Medical Affairs Director Comments & Decision Rationale
Required Follow-Up Actions (select all that apply)
Send Medical Information Response Letter
Conduct Literature Search & Synthesis
Schedule Follow-Up Call with HCP
Prepare Custom Scientific Presentation
Escalate to Global Medical Affairs
Initiate Advisory Board Discussion
Update Medical Information Database
No Further Action Required
Does this require escalation to Drug Safety Committee?
Should this inquiry be shared with Global Medical Affairs network?
Key Scientific References & Evidence Sources for Response
Upload Supporting Documentation - Notes, Publications, or Relevant Materials
MSL Digital Signature & Attestation
Final Form Completion Date & Time
To configure an element, select it on the form.