NCT04301219

Brief Summary

The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

November 26, 2019

Last Update Submit

March 5, 2020

Conditions

Adverse Reaction

Outcome Measures

Primary Outcomes (2)

  • Country-wise Analysis on knowledge of HCPs

    Number of HCPs had knowledge about AR in their own country

    2 years

  • Country-wise Analysis on practices of HCPs

    Number of HCPs practicing AR reporting in their own country

    2 years

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A self-administered questionnaire was distributed to 1500 HCPs in 11 countries (Afghanistan, Cambodia, Kazakhstan, Kenya, Laos, Myanmar, Nigeria, Pakistan, Philippines, Sri Lanka, and Sudan). The participants were approached at various scientific events and academic interactions during the period and were requested to participate in the survey on a voluntary basis.

You may qualify if:

  • \- Participants who would like to voluntarily fill the survey form

You may not qualify if:

  • Students
  • Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University

Karachi, Sindh, Pakistan

Location

Study Officials

  • Mahwish Raza, Pharm-D

    Shaheed Zulfiqar Ali Bhutto Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

March 10, 2020

Study Start

April 1, 2017

Primary Completion

March 1, 2018

Study Completion

December 1, 2018

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

PA(1)