Adverse Reporting Form-English - Macleods

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Report an Adverse Event

English | Arabic

CONTACT INFORMATION

Full Name

Occupation

Patient Relation

Email

Mobile*

REQUEST INFORMATION

Request Type*

Trade Name, Strength

Dosage Form

Registration Number

Batch Number

Manufacturing Date

Expiration Date

Description

Attached File (PDF,IMG)

Generic Name*

Batch Number*

Description

Is Drug Effective *YesNo

Batch Number

Manufacturing Date

Expiration Date

How did you obtain the medicationFrom the pharmacy with a prescriptionFrom the pharmacy without a prescriptionFrom other stores (not a pharmacy)

Name of the store or pharmacy from which the medication was dispensed

Address of the store or pharmacy from which the medication was dispensed

Purpose of Use

GenderMaleFemale

Description

GenderMaleFemale

Description

SUSPECTED DRUGS INFO

Suspected Drugs

Start Date

End Date

Purpose of Use *

PATIENT INFORMATION

Full Name

Date Of Birth

Height (cm)

Weight (kg)

PRODUCT DETAILS (OPTIONAL)

Generic Name

How did you obtain the medication

Name and address of the store or pharmacy from which the medication was dispensed

Purpose of Use

Strength

Start Date

Did you stop using the medication?YesNo

SIDE EFFECT

Date of Event Started

Seriousness of ADRNon-seriousLife ThreateningPermanent DisabilityHospitalizationProlonged Hospitalization More Than 24 HrCongenital AnomalyRequired Intervention to Prevent Permanent Impairment / DamageOther

Date of Event Ended

Did you inform the doctor or pharmacist of these adverse event?YesNoUnknown

If Yes, Did he/she file an adverse event reporting form?YesNoUnknown

Can we obtain further information from your treating physicianYesNoUnknown

If yes, please provide us with the communication information of the treating physician

Description of Event

CONCOMITANT DRUGS (OPTIONAL)

Trade Name

Strength

Start Date

End Date

Purpose of Use

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Key divisions

Clinical
Bioanalytical
Pharmacokinetic and statistical
Quality Assurance
Data Protection

Clinical

Spread across 27,400 sq. ft, in Mumbai and Ahmedabad.
Supported by a NABL accredited clinical lab that has advanced machines such as Dimension EXL 200 (biochemistry), Sysmex XN 550 (haematology) and a LIS system to record, manage and store lab data.
Subject registrations carried out, using biometrics
Subject screening carried out to ensure stringent compliances (staging, height/ weight and volunteer registration, doctors’ room, ECG and X-ray).
Dosing and phlebotomy area available.

Pharmacy with controlled condition storage available.
Comprises of clinical pharmacological unit (CPU), with 248 beds.
Sample separation and storage room available, with a capacity for 48,000+ samples.
Round-the-clock monitoring is carried out by qualified doctors.
Contains a fully-equipped ICU.

Bioanalytical

Spread across 7700 sq. ft.
Facilitates method development and validation from human matrices (blood, serum, plasma and urine).
Has carried out 400+ validated methods.
Equipped for investigative procedures for low detection, chiral assays, light sensitivity, unstable molecules and conjugated and unconjugated assays.
Studies on invitro equilibrium phosphate and bile salts binding carried out.

Facilitates invitro release test (IVRT) and invitro permeation test (IVPT) on cadaver skin.
Comprises of a laboratory outfitted with 20 LC/MS/MS highly sensitive equipment.
Facility for controlled sample storage with a capacity for 32,000+ samples available.
Equipped with 21 CFR-compliant software (Analyst/ Chromleon/ Diffusion Master)

Pharmacokinetic and statistical

This is a SAS-powered statistical analysis software unit.
Enables two/ three/ four-way crossover BE studies as well as replicate crossover studies.
Facilitates parallel BE studies and steady-state BE studies.
Facilitates Invitro studies.
Facilitates Skin blanching studies.

Quality Assurance

Strictly adheres to GCP, GLP and regulatory requirements through online and retrospective audits.
Carries out in-house system and facility audits and outsourced services.
Has SOPs to ensure the uniformity of procedures, across the clinical, analytical and statistical sections.

Data Protection

Controlled access available, to ensure data confidentiality and integrity.
Dedicated servers available for software and laboratory data.
Separate archiving area for the documentation resulting from the QA procedures available.