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“headline”: “SOP for DCGI NOC/CTA and Protocol Amendment Submissions”,
“description”: “This SOP provides step-by-step procedures for obtaining DCGI No Objection Certificate (NOC), Clinical Trial Application (CTA) approvals, and submitting protocol amendments in compliance with CDSCO and Indian GCP guidelines.”,
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Standard Operating Procedure for DCGI NOC/CTA and Protocol Amendment Submissions

Purpose

The purpose of this SOP is to define procedures for submitting Clinical Trial Applications (CTAs), obtaining No Objection Certificates (NOCs), and managing protocol amendments with the Drugs Controller General of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO). It ensures compliance with Indian GCP (2019), New Drugs and Clinical Trials Rules, 2019, and aligns with global regulatory expectations.

Scope

This SOP applies to sponsors, CROs, investigators, and regulatory affairs staff involved in clinical trials conducted in India. It covers preparation, submission, tracking, and approval of initial CTAs, NOCs, and protocol amendments, along with responsibilities for documentation and archiving.

Responsibilities

• Sponsor: Prepares and submits complete dossiers for DCGI approvals.
• Regulatory Affairs: Manages submission to SUGAM portal, ensures timelines, and communicates with CDSCO.
• CRO: Provides operational and documentation support for regulatory submissions.
• Investigator: Ensures site-level documentation is aligned with approved protocols.
• QA: Reviews submission packages for accuracy and compliance.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for all submissions and amendments to DCGI and ensuring adherence to timelines.

Procedure

1. Preparation of CTA/NOC Dossier
1.1 Compile documents: protocol, IB, IMPD, investigator CVs, ethics approvals.
1.2 Submit electronically via SUGAM portal.
1.3 Record submission in CTA Submission Log (Annexure-1).

2. DCGI Review Process
2.1 Monitor application status via SUGAM.
2.2 Respond to DCGI queries within stipulated timelines.
2.3 Record in DCGI Query Response Log (Annexure-2).

3. Protocol Amendment Submissions
3.1 Identify substantial vs. non-substantial amendments.
3.2 Submit substantial amendments to DCGI with justification.
3.3 Track approval in Amendment Submission Log (Annexure-3).

4. Approval and Communication
4.1 Notify investigators and sites upon DCGI approval.
4.2 Archive approval letters in TMF.
4.3 Record in Approval Notification Log (Annexure-4).

5. Archiving
5.1 Archive all CTA/NOC/protocol amendment documentation in TMF and ISF.
5.2 Maintain inspection readiness for DCGI audits.

Abbreviations

• SOP: Standard Operating Procedure
• CTA: Clinical Trial Application
• NOC: No Objection Certificate
• DCGI: Drugs Controller General of India
• CDSCO: Central Drugs Standard Control Organization
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. CTA Submission Log (Annexure-1)
2. DCGI Query Response Log (Annexure-2)
3. Amendment Submission Log (Annexure-3)
4. Approval Notification Log (Annexure-4)

References

• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: CTA Submission Log

Annexure-2: DCGI Query Response Log

Annexure-3: Amendment Submission Log

Annexure-4: Approval Notification Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for AV Recording of Consent (NCEs; Defined Therapy Areas) and Retention”,
“description”: “This SOP defines procedures for mandatory audio-visual (AV) recording of informed consent in Indian clinical trials involving new chemical entities (NCEs) and defined therapy areas. It covers technical requirements, storage, retention, and compliance with DCGI/CDSCO and NDCTR 2019 rules.”,
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Standard Operating Procedure for AV Recording of Consent (NCEs; Defined Therapy Areas) and Retention

Purpose

The purpose of this SOP is to establish standardized procedures for mandatory audio-visual (AV) recording of the informed consent process in clinical trials involving New Chemical Entities (NCEs) and specific therapy areas as required by the Drugs Controller General of India (DCGI) under the New Drugs and Clinical Trials Rules (NDCTR), 2019. It ensures subject rights, transparency, and regulatory compliance.

Scope

This SOP applies to investigators, sponsors, CROs, ethics committees, and site staff involved in clinical trials requiring AV recording of consent. It covers equipment requirements, recording procedures, secure storage, retention timelines, and regulatory audit preparedness.

Responsibilities

• Investigator: Ensures AV recording is performed for every informed consent interaction where mandated.
• Sponsor: Provides resources and oversight for AV recording and storage systems.
• CRO: Monitors compliance with AV recording SOPs across trial sites.
• EC/IRB: Verifies AV consent documentation during continuing reviews.
• QA: Audits AV recording practices and storage compliance.

Accountability

The Principal Investigator (PI) is accountable for ensuring AV recording of consent is properly executed, documented, and retained in compliance with NDCTR 2019 and DCGI notifications.

Procedure

1. Equipment Setup
1.1 Ensure recording equipment is functional and located in a private, secure space.
1.2 Test audio and video quality before initiating consent discussions.
1.3 Document setup in AV Equipment Log (Annexure-1).

2. Recording Consent
2.1 Begin recording before initiation of consent explanation.
2.2 Capture full interaction: explanation of trial, subject questions, voluntary agreement.
2.3 Record both subject and investigator identities.
2.4 Document in AV Consent Recording Log (Annexure-2).

3. Retention and Storage
3.1 Store recordings securely in encrypted systems or locked physical storage devices.
3.2 Retain recordings for a minimum of 25 years as per NDCTR requirements.
3.3 Record storage details in AV Storage Log (Annexure-3).

4. Data Confidentiality
4.1 Restrict access to authorized personnel only.
4.2 Record all access events in AV Access Log (Annexure-4).

5. Protocol Amendments
5.1 If therapy area or scope expands, update AV consent process accordingly.
5.2 Track amendments in AV Protocol Amendment Log (Annexure-5).

6. Audit and Inspection
6.1 Ensure inspection readiness of AV recordings for DCGI and EC audits.
6.2 Document audits in AV Audit Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• AV: Audio-Visual
• NCE: New Chemical Entity
• DCGI: Drugs Controller General of India
• CDSCO: Central Drugs Standard Control Organization
• CRO: Contract Research Organization
• QA: Quality Assurance
• NDCTR: New Drugs and Clinical Trials Rules
• EC/IRB: Ethics Committee/Institutional Review Board

Documents

1. AV Equipment Log (Annexure-1)
2. AV Consent Recording Log (Annexure-2)
3. AV Storage Log (Annexure-3)
4. AV Access Log (Annexure-4)
5. AV Protocol Amendment Log (Annexure-5)
6. AV Audit Log (Annexure-6)

References

• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: AV Equipment Log

Annexure-2: AV Consent Recording Log

Annexure-3: AV Storage Log

Annexure-4: AV Access Log

Annexure-5: AV Protocol Amendment Log

Annexure-6: AV Audit Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for SAE Compensation Assessment, Payment, and Reporting Timelines”,
“description”: “This SOP outlines procedures for assessing, compensating, and reporting Serious Adverse Events (SAEs) in Indian clinical trials. It ensures compliance with DCGI/CDSCO guidelines, NDCTR 2019, and subject rights protection, covering assessment, timelines, payment, and reporting obligations.”,
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Standard Operating Procedure for SAE Compensation Assessment, Payment, and Reporting Timelines

Purpose

The purpose of this SOP is to define procedures for the assessment, payment, and reporting of Serious Adverse Event (SAE) compensation in clinical trials conducted in India. It ensures compliance with the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), and New Drugs and Clinical Trials Rules (NDCTR), 2019. The SOP safeguards participant rights and ensures transparency in compensation timelines.

Scope

This SOP applies to sponsors, CROs, investigators, and ethics committees involved in clinical trials conducted in India where SAEs result in trial-related injury or death. It covers SAE assessment, compensation calculation, payment timelines, reporting to DCGI and ethics committees, and documentation.

Responsibilities

• Sponsor: Assesses SAE compensation liability, arranges for timely payment, and reports to DCGI/EC.
• Investigator: Reports SAEs within 24 hours, provides required medical documentation, and supports compensation process.
• CRO: Coordinates assessment and reporting on behalf of sponsor.
• EC: Reviews SAE assessment reports and approves compensation decisions.
• QA: Audits SAE reporting and payment records for compliance.

Accountability

The Sponsor’s Medical and Regulatory Affairs Head is accountable for timely SAE compensation assessment, disbursement, and regulatory reporting compliance.

Procedure

1. SAE Reporting
1.1 Investigator reports SAE to sponsor, EC, and DCGI within 24 hours.
1.2 Document in SAE Initial Report Log (Annexure-1).

2. Causality Assessment
2.1 Sponsor’s Independent Expert Committee conducts causality assessment within 30 days.
2.2 Record decision in SAE Causality Assessment Log (Annexure-2).

3. Compensation Calculation
3.1 Compensation calculated as per DCGI formula (NDCTR, 2019).
3.2 Record calculation details in Compensation Calculation Log (Annexure-3).

4. EC Review
4.1 Submit assessment and proposed compensation to Ethics Committee for approval.
4.2 Document review outcome in EC Review Log (Annexure-4).

5. Payment Execution
5.1 Disburse compensation within 30 days of EC/DCGI approval.
5.2 Record transaction in Compensation Payment Log (Annexure-5).

6. Reporting Timelines
6.1 Final compensation report submitted to DCGI and EC within 45 days of SAE reporting.
6.2 Archive all reports in TMF and ISF.

Abbreviations

• SOP: Standard Operating Procedure
• SAE: Serious Adverse Event
• EC: Ethics Committee
• DCGI: Drugs Controller General of India
• CDSCO: Central Drugs Standard Control Organization
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• NDCTR: New Drugs and Clinical Trials Rules

Documents

1. SAE Initial Report Log (Annexure-1)
2. SAE Causality Assessment Log (Annexure-2)
3. Compensation Calculation Log (Annexure-3)
4. EC Review Log (Annexure-4)
5. Compensation Payment Log (Annexure-5)

References

• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: SAE Initial Report Log

Annexure-2: SAE Causality Assessment Log

Annexure-3: Compensation Calculation Log

Annexure-4: EC Review Log

Annexure-5: Compensation Payment Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for EC Registration Verification and Communications (Country-Specific)”,
“description”: “This SOP defines procedures for verifying Ethics Committee (EC) registrations with DCGI and ensuring proper country-specific communications. It establishes sponsor, investigator, and CRO responsibilities to maintain compliance with NDCTR 2019 requirements and CDSCO regulations.”,
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Standard Operating Procedure for EC Registration Verification and Communications (Country-Specific)

Purpose

The purpose of this SOP is to establish procedures for verifying Ethics Committee (EC) registrations and managing communications with ECs in compliance with the Drugs Controller General of India (DCGI), CDSCO, and the New Drugs and Clinical Trials Rules (NDCTR) 2019. This ensures that all ECs involved in clinical trials are properly registered and that communications meet country-specific regulatory requirements.

Scope

This SOP applies to sponsors, CROs, investigators, and regulatory affairs personnel involved in Indian clinical trials. It covers verification of EC registration with CDSCO, documentation of communications, and reporting obligations to ensure compliance with NDCTR and ICMR guidelines.

Responsibilities

• Sponsor: Ensures all trial ECs are registered and maintains EC registration records in the TMF.
• Investigator: Confirms EC registration at site and provides updates to sponsor/CRO.
• CRO: Verifies EC registration for participating sites and tracks communications.
• EC: Maintains valid registration, renewals, and responds to sponsor/authority communications.
• QA: Audits EC registration verification and communications for compliance.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for ensuring EC registration verification and documentation of all communications.

Procedure

1. Verification of EC Registration
1.1 Collect EC registration details from sites prior to trial initiation.
1.2 Verify registration against CDSCO’s official EC registry.
1.3 Document in EC Registration Verification Log (Annexure-1).

2. Renewal Tracking
2.1 Ensure EC registrations remain valid throughout trial duration.
2.2 Document in EC Renewal Tracking Log (Annexure-2).

3. Communication Management
3.1 Maintain official communications (queries, approvals, acknowledgments).
3.2 Archive communications in TMF and ISF.
3.3 Record in EC Communications Log (Annexure-3).

4. Non-Compliance Handling
4.1 If EC is not registered, escalate to sponsor and regulatory authority.
4.2 Document in Non-Compliance Log (Annexure-4).

5. Inspection Readiness
5.1 Ensure EC registrations and communications are audit-ready.
5.2 Document periodic QA checks in EC Audit Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• EC: Ethics Committee
• DCGI: Drugs Controller General of India
• CDSCO: Central Drugs Standard Control Organization
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• NDCTR: New Drugs and Clinical Trials Rules
• ICMR: Indian Council of Medical Research

Documents

1. EC Registration Verification Log (Annexure-1)
2. EC Renewal Tracking Log (Annexure-2)
3. EC Communications Log (Annexure-3)
4. Non-Compliance Log (Annexure-4)
5. EC Audit Log (Annexure-5)

References

• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019
• ICMR – National Ethical Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: EC Registration Verification Log

Annexure-2: EC Renewal Tracking Log

Annexure-3: EC Communications Log

Annexure-4: Non-Compliance Log

Annexure-5: EC Audit Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for Site Capability for Emergency Care Verification and Documentation”,
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Standard Operating Procedure for Site Capability for Emergency Care Verification and Documentation

Purpose

The purpose of this SOP is to define the process for verifying and documenting the capability of investigator sites to provide emergency medical care during clinical trials. It ensures participant safety, compliance with DCGI/CDSCO guidelines, and readiness for handling trial-related medical emergencies in accordance with Indian GCP and NDCTR 2019.

Scope

This SOP applies to sponsors, CROs, investigators, and site staff engaged in clinical trials conducted in India. It covers assessment of facilities, verification of emergency preparedness, documentation of hospital backup agreements, and regulatory inspection readiness.

Responsibilities

• Sponsor: Ensures all trial sites have adequate emergency care facilities and documentation.
• Investigator: Confirms availability of emergency care services and maintains records.
• CRO: Conducts site capability verification and reports findings to sponsor.
• EC: Reviews site preparedness documentation during trial approval.
• QA: Audits site records to ensure compliance and inspection readiness.

Accountability

The Principal Investigator (PI) is accountable for maintaining and demonstrating site readiness for emergency care at all times during the trial.

Procedure

1. Site Capability Assessment
1.1 Assess availability of emergency care equipment (defibrillators, oxygen supply, crash cart).
1.2 Confirm presence of trained medical staff capable of handling emergencies.
1.3 Record in Site Capability Assessment Log (Annexure-1).

2. Hospital Backup Arrangements
2.1 Ensure documented agreements with nearby hospitals for emergency referral.
2.2 Verify signed Memorandum of Understanding (MoU).
2.3 Record in Hospital Backup Documentation Log (Annexure-2).

3. Documentation and Verification
3.1 Maintain emergency preparedness documentation in ISF and TMF.
3.2 Verify during site initiation visits.
3.3 Document findings in Site Verification Log (Annexure-3).

4. Training
4.1 Conduct site staff training on emergency preparedness procedures.
4.2 Document in Training Log (Annexure-4).

5. Inspection Readiness
5.1 Ensure records are accessible for DCGI and EC inspections.
5.2 Conduct internal QA checks and record in Audit Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• EC: Ethics Committee
• DCGI: Drugs Controller General of India
• CDSCO: Central Drugs Standard Control Organization
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• NDCTR: New Drugs and Clinical Trials Rules
• PI: Principal Investigator

Documents

1. Site Capability Assessment Log (Annexure-1)
2. Hospital Backup Documentation Log (Annexure-2)
3. Site Verification Log (Annexure-3)
4. Training Log (Annexure-4)
5. Audit Log (Annexure-5)

References

• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019
• ICMR – National Ethical Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: Site Capability Assessment Log

Annexure-2: Hospital Backup Documentation Log

Annexure-3: Site Verification Log

Annexure-4: Training Log

Annexure-5: Audit Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for Local Lab Accreditation Verification and Documentation (India-Specific)”,
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Standard Operating Procedure for Local Lab Accreditation Verification and Documentation (India-Specific)

Purpose

The purpose of this SOP is to outline the procedure for verifying and documenting the accreditation of local laboratories used in Indian clinical trials. This ensures compliance with DCGI/CDSCO and New Drugs and Clinical Trials Rules (NDCTR 2019), while safeguarding data integrity, reliability, and subject safety. Accreditation primarily refers to NABL (National Accreditation Board for Testing and Calibration Laboratories) certification or equivalent.

Scope

This SOP applies to sponsors, CROs, investigators, QA, and site staff responsible for selecting, verifying, and using local laboratories for clinical trial sample analysis in India. It covers accreditation verification, documentation, and maintenance of records in TMF and ISF for regulatory inspections.

Responsibilities

• Sponsor: Ensures that all trial laboratories used are appropriately accredited and compliant with regulations.
• CRO: Conducts verification of lab accreditation and communicates findings to the sponsor.
• Investigator: Confirms that site laboratories hold valid accreditation.
• QA: Audits lab records to ensure accreditation and inspection readiness.
• Laboratory: Maintains valid accreditation and provides updated certificates.

Accountability

The Sponsor’s Regulatory Affairs and QA Heads are accountable for ensuring valid accreditation of laboratories used in Indian clinical trials and proper documentation of all certificates.

Procedure

1. Laboratory Selection and Verification
1.1 Obtain accreditation certificate (NABL or equivalent) from each laboratory.
1.2 Verify certificate validity on NABL website or issuing authority.
1.3 Record in Lab Accreditation Verification Log (Annexure-1).

2. Documentation
2.1 File accreditation certificates in TMF and ISF.
2.2 Maintain copies at sponsor and CRO levels.
2.3 Record in Accreditation Document Log (Annexure-2).

3. Renewal Tracking
3.1 Track certificate expiration dates.
3.2 Request updated accreditation certificates before expiry.
3.3 Record in Renewal Tracking Log (Annexure-3).

4. Non-Compliant Laboratories
4.1 Do not use non-accredited laboratories.
4.2 Document issues in Non-Compliance Log (Annexure-4).

5. Audit and Inspection
5.1 Maintain inspection-ready accreditation records.
5.2 Conduct periodic audits recorded in Lab Audit Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• EC: Ethics Committee
• DCGI: Drugs Controller General of India
• CDSCO: Central Drugs Standard Control Organization
• NABL: National Accreditation Board for Testing and Calibration Laboratories
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• NDCTR: New Drugs and Clinical Trials Rules

Documents

1. Lab Accreditation Verification Log (Annexure-1)
2. Accreditation Document Log (Annexure-2)
3. Renewal Tracking Log (Annexure-3)
4. Non-Compliance Log (Annexure-4)
5. Lab Audit Log (Annexure-5)

References

• National Accreditation Board for Testing and Calibration Laboratories (NABL)
• CDSCO – Central Drugs Standard Control Organization
• New Drugs and Clinical Trials Rules, 2019

Version: 1.0

Approval Section

Annexures

Annexure-1: Lab Accreditation Verification Log

Annexure-2: Accreditation Document Log

Annexure-3: Renewal Tracking Log

Annexure-4: Non-Compliance Log

Annexure-5: Lab Audit Log

Revision History

For more SOPs visit: Pharma SOP