## Protocol Section
### Identification Module
**NCT ID:** NCT06428162

**Brief Title:** a Cross-sectional Study of Pharmacovigilance Practices Adherence Between Healthcare Providers in North African Nation

**Official Title:** an Observational Study for the Prevalence of Pharmacovigilance Practices Between Healthcare Providers in North African Nation

#### Organization Study ID Info
**ID:** 2024 PV
#### Organization
**Class:** OTHER
**Full Name:** Deraya University
### Status Module
#### Completion Date
**Date:** 2024-06-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Start Date
**Date:** 2024-02-18

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Deraya University

#### Responsible Party

**Investigator Affiliation:** Deraya University

**Investigator Full Name:** Soad Ali

**Investigator Title:** associate professor of pharamcy practices, faculaty of pharmacy, Deraya University

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** a predesignated survey about information on drug adverse events and pharmacovigilance role in detection and reporting was distributed in different regions (urban/rural/mixed) in Egypt. the survey composed of three sections; demographics, person reported or not reported and was directed for health care providers to study their awareness about pharmacovigilance cores and its practices. additionally the survey included further questions about reported adverse events.

### Conditions Module

**Conditions:**

- Drug Reaction

- Drug Hypersensitivity

- Drug Abuse

- Drug Interaction

### Design Module

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 300

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** three sections questioner including: demographics, reported cases, unreported cases

**Name:** questionner

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** collect recent adverse drug reaction reports

**Measure:** reported adverse drug reactions

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* all health care providers are invited to share in the study
* minimum experience required is one year in health carrier.
* accept sharing in the study

Exclusion Criteria:

* health care providers who refuse to complete all data required in the survey.
* fresh experience or participants who left health carrier

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 25 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** all health care providers that deals with drugs and medications as pharmacists, physicians, Dentists, nurses and medical reps are invited to share in this survey as a hard template. study included 300 subject in different disciplines at the period at 3 months. complete survey composed of 3 sections included previous reported ADVEs

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Minya

**Country:** Egypt

**Facility:** Deraya university

**Zip:** 05673

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007154

- Term: Immune System Diseases

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: HIGH

- As Found: Hypersensitivity

- ID: M30303

- Name: Drug-Related Side Effects and Adverse Reactions

- Relevance: HIGH

- As Found: Drug Reactions

- ID: M7517

- Name: Drug Hypersensitivity

- Relevance: HIGH

- As Found: Drug Hypersensitivity

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: HIGH

- As Found: Drug Abuse

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006967

- Term: Hypersensitivity

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064420

- Term: Drug-Related Side Effects and Adverse Reactions

- ID: D000004342

- Term: Drug Hypersensitivity

### Misc Info Module

- Version Holder: 2024-05-31
