INVESTIGATION PRODUCT COMPLAINT (FORM M)
Division of Allergy, Immunology and Transplantation (DAIT) National Institute of Allergy and Infectious
Diseases (NIAID) National Institutes of Health (NIH)
INSTRUCTIONS ON HOW TO COMPLETE Form M
Pharmacist of Record (PoR)/ Study Personnel
1. Type or handwrite legibly. File a copy of this form in the study Pharmacy Binder.
2. Provide a detailed complaint description in Section C of this form.
3. If an associated Adverse Event (AE) or Serious Adverse Event (SAE) occurs, in addition to completing
this form, complete and submit an AE/SAE electronic case report form (eCRF) in Electronic Data
Capture (EDC). The PoR will communicate with the study coordinator & Principal Investigator (PI) to
complete the eCRF.
4. If an associated Protocol Deviation (PD) related to the product occurs (e.g. when a defective/
damaged/malfunctioned product/ Device has been prepared and/or administered to/ for a participant
OR participant did not receive IP on schedule as per protocol due to any of the stated reasons), in
addition to completing this form, complete and submit PD eCRF in EDC. The PoR will communicate
with the study coordinator to complete the eCRF.
5. Include Participant ID # when a defective/ damaged/ malfunctioned Product/ Device has been
prepared and/or administered to/ for a participant.
6. This form must be filled out and submitted** within 24 hours of event occurrence by email or fax to:
a) EMINENT Services Corporation; [email protected], Fax: (240) 629-3298, Tel: (240)
629-1972
AND
b) DAIT Pharmacists/ Pharmaceutical Specialist; [email protected], Tel:(301)761-6462
or (240) 627-3512.
7. Do not send any affected Product(s) or Device(s) prior to receiving an authorization from DAIT
Pharmaceutical Specialist (PS).
DAIT Pharmaceutical Specialist (PS):
1. Upon receipt of complaint Form M, DAIT PS to assign a product complaint number and notify DAIT
Project Manager (PM), Medical Monitor (MM) and Safety (in a blinded fashion for blinded studies).
Provide safety report # when applicable.
2. DAIT PS to report complaint to DAIT Clinical Product Center (CPC) EMINENT Services Corporation
and Manufacturer (if applicable) within 72 hours of receipt.
3. If products are not purchased, DAIT PS to report the complaint to Manufacturer within 72 hours and
inform DAIT PM, MM, Regulatory and provide report references.
4. For complaints requiring mandatory safety reporting to Health Authorities (HA), DAIT PS to
communicate with DAIT Regulatory, Safety and Clinical team to ensure a MedWatch FDA Form
3500A is filed by the responsible entity.
DAIT Clinical Products Center (CPC):
1. Upon receipt of Form M, DAIT CPC to immediately inform DAIT PS.
2. If products are purchased, DAIT CPC to report the complaint to Manufacturer within 72 hours,
inform DAIT PS and provide report references.
3. If products are not purchased, refer to DAIT PS section here.
** This form may contain information susceptible to unblind the blinded study
staff. Please ensure blinding is maintained during communications.
INVESTIGATIONAL PRODUCT/ DEVICE COMPLAINT (FORM M)
Division of Allergy, Immunology and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Research Site Name: Research Site Number:
Study Name & Number : Investigator's Name:
Participant ID # (if Applicable): Date Event/ Complaint Occurred:
A. Investigational Product (IP) or Device Information
Product/ Device Name:
Strength/Dosage Form/Formulation (if applicable):
# of Affected Products: Manufacturer: Lot Number:
Unique #(s) or Kit #(s) (if Applicable): Expiration Date:
Package Size:
B. Type of Product/ Device Complaint Comments
☐
Damaged Product/ Device Carton; Including Missing or Illegible Labeling
☐
Damaged Product/ Device (i.e. cracked/broken vial, syringes, bottles, etc.)
☐
Damaged Shipping Box (If available, include shipment ID number)
☐ Product/ Device Malfunction or Incomplete Dose During Preparation or Administration
☐ Unexpected Color Appearance; Particles Observed in Product/ Device
Other (Suspected Transmission of Infectious Agent by Medical Product (STIAMP) or etc.
C. Complaint Details/ Description (Attach pictures if available)
☐Product/ Device Available for Return
☐Picture(s) Available (If Yes, Attach Pictures)
☐Product/ Device was Prepared for Participant(s)
☐Product/ Device was Administered or Used in Participant(s)
☐Adverse Event (AE) or SAE Occurred; If Yes, Submit AE/SAE in EDC
☐Pr
otocol Deviation Occurred; If Yes, Submit a Protocol Deviation in EDC
Pharmacist of Record or Site Personnel Reporting Complaint:
Name: Signature: Date:
NIAID/DAIT USE ONLY
1. Notified DAIT: PM MM RO
Yes NA
Date:
2. DAIT Safety Notified:
Yes NA
Date:
☐ ☐
☐ ☐
3. Complaint Reported to Manufacturer
Yes☐NA☐
Date:
4. AE/SAE eCRF Submitted from Site: Yes NA
If Yes, AE/SAE Report# (If Applicable):
Date:
5. Complaint Required Mandatory Reporting via FDA Form 3500A to HA
Yes NA
Date:
DAIT PS Signature & Date (for Blinded Studies): DAIT PM Signature & Date (for Unblinded Studies ONLY):
DAIT CPC USE ONLY
If Product Purchased, Complaint Reported to Manufacturer :
Yes☐ No☐ Date
CPC Personnel Receiving the Complaint (Name Signature):
Product Complaint #
☐
Under SOP Review Committee
