01 / Find the source
Regulatory resources
Nepal and international authority links remain freely accessible.
Regulatory & research library
Documents for the
work ahead.
Official regulatory resources. Practical working templates. Independent use or NCR draft-to-final document support.
02 / Request access
Working templates
Preview page one, then submit your contact and organization details for administrator review.
03 / Work with NCR
Draft-to-final support
Agree scope, reviewers, revisions and deliverables before engagement.
How access worksOfficial authority links open directly. NCR templates show a first-page preview; complete documents require a request and administrator approval. Templates still require qualified study-specific review.
The collection
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66 resources found
Complete collectionNepal regulatory
NHRC — National Ethical Guidelines for Health Research in Nepal (2022)
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- Nepal
- Stage
- Across the lifecycle
Official source · direct access
Nepal regulatory
NHRC — Guidelines for Institutional Review Committees (2016)
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- Nepal
- Stage
- Across the lifecycle
Official source · direct access
Nepal regulatory
Department of Drug Administration — Regulatory role
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- Nepal
- Stage
- Across the lifecycle
Official source · direct access
Nepal regulatory
Nepal Law Commission — Drug Registration Rules, 2038
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- Nepal
- Stage
- Across the lifecycle
Official source · direct access
Nepal regulatory
DDA — Health Technology Product and Equipment Directive, 2074 (2017)
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- Nepal
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
WHO — Primary registries in the clinical trials registry network
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- International
- Stage
- Across the lifecycle
Official source · direct access
Nepal regulatory
WHO — Nepal national online ethical review system initiative (2024)
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- Nepal
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
ICH — E6(R3) Good Clinical Practice, Principles and Annex 1 (2025)
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- International
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
ICH — E6(R3) Good Clinical Practice, Annex 2 (3 June 2026)
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- International
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
WMA — Declaration of Helsinki (2024)
Official-source reference for study planning. Check the publisher for the current version, applicability and any amendments before use.
- Jurisdiction
- International
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
US FDA clinical trials guidance
FDA guidance catalogue covering clinical trials and human-subject protection; individual entries may be draft or final.
- Jurisdiction
- United States
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
EU clinical trials regulation and CTIS
EMA overview and links to the Clinical Trials Regulation and CTIS resources.
- Jurisdiction
- EU / EEA
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
Japan clinical trial regulatory resources
PMDA clinical-trial resources and English-language reference materials; consult the controlling Japanese texts where applicable.
- Jurisdiction
- Japan
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
Australia clinical trial pathways
TGA resources for clinical-trial access pathways and related application guidance.
- Jurisdiction
- Australia
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
China drug registration provisions
NMPA English-language drug registration provisions, including clinical-trial provisions. Check amendments and the authoritative Chinese text.
- Jurisdiction
- China
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
UK clinical trial authorisation guidance
UK government guidance for medicines clinical-trial authorisation. Review current transitional requirements with the regulator.
- Jurisdiction
- United Kingdom
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
Canada clinical trial application and authorisation
Health Canada guidance on clinical-trial application and authorisation under the drug regulations.
- Jurisdiction
- Canada
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
Singapore clinical trial regulatory guidance
HSA guidance documents for clinical-trial submissions and related requirements.
- Jurisdiction
- Singapore
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
India investigational new drug resources
CDSCO investigational new drug resources and links to the New Drugs and Clinical Trials Rules.
- Jurisdiction
- India
- Stage
- Across the lifecycle
Official source · direct access
International regulatory
South Africa clinical trial guidelines
SAHPRA clinical-trial guidelines catalogue. Check each entry’s revision and publication date before use.
- Jurisdiction
- South Africa
- Stage
- Across the lifecycle
Official source · direct access
Clinical trial templates
Protocol development template
Define the rationale, objectives, endpoints, study design and participant protections.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Protocol synopsis
Summarise the study design for coordinated review without replacing the full protocol.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Country and site feasibility assessment
Document feasibility evidence and unresolved operational dependencies.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Study risk assessment
Assess risks to participants and reliable study results with named controls.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Study management plan
Set responsibilities, communication routes and decision ownership.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Quality management plan
Plan proportionate oversight and quality checks for the specific study.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Monitoring plan
Specify study-specific monitoring activities and escalation.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Data management plan
Define data flow, checks, access and database decisions.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Statistical analysis plan outline
Structure a statistician-led analysis plan linked to the protocol.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Investigator brochure content checklist
Track required scientific inputs for a sponsor-authored investigator brochure.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Clinical trial templates
Ethics submission package checklist
Track the applicable ethics submission package and authority-specific requirements.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Regulatory submission tracker
Track actual submissions, authority queries and decisions.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Participant information sheet outline
Plan understandable participant-facing information for protocol-specific review.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Informed consent form outline
Record consent decisions using approved participant-facing language.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Recruitment materials review checklist
Review recruitment wording and approval dependencies before use.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Site qualification visit report
Record site readiness evidence and follow-up decisions.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Site initiation visit report
Record initiation activities and unresolved readiness conditions.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Delegation of duties log
Record delegated study duties and effective periods.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Study training log
Track completion of study-specific training and refreshers.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Essential document index
Plan the sponsor/site records applicable to the study and their locations.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Site contact and escalation list
Maintain controlled operational and safety contact routes.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Clinical trial templates
Screening and enrolment log
Track screening outcomes using coded identifiers and controlled access.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Consent process tracking log
Track consent and re-consent against approved versions.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Participant visit tracking log
Track protocol visits and missing or rescheduled activities.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Case report form design worksheet
Plan CRF fields from protocol endpoints and source evidence.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Protocol deviation log
Track deviations, impact assessment and corrective actions.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Adverse event assessment worksheet
Support investigator assessment; it does not replace approved safety forms.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Serious adverse event reporting tracker
Track study-specific urgent reporting and follow-up obligations.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Investigational product accountability log
Reconcile product receipt, dispensing, returns and disposition.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Medical device accountability log
Track study-device identity, allocation and disposition.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Temperature excursion record
Document storage excursions and authorised product-use decisions.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Sample shipment and reconciliation log
Track coded sample handling and chain-of-custody handovers.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Monitoring visit report
Document monitoring findings and agreed follow-up.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Action item and query tracker
Track owners and evidence for resolving operational actions.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Corrective and preventive action plan
Document root-cause analysis and effectiveness checks.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Amendment and version control log
Track revisions and implementation conditions.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Annual progress report worksheet
Assemble progress information against the relevant authority checklist.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Clinical trial templates
Close-out visit report
Document site reconciliation and outstanding close-out actions.
- Jurisdiction
- International
- Stage
- Close-out
First-page preview · request required for download
Clinical trial templates
Essential document reconciliation checklist
Reconcile expected records and documented exceptions.
- Jurisdiction
- International
- Stage
- Close-out
First-page preview · request required for download
Clinical trial templates
Archiving and retention plan
Define record custody and retention from applicable requirements.
- Jurisdiction
- International
- Stage
- Close-out
First-page preview · request required for download
Clinical trial templates
Clinical study report outline
Structure a scientific report from verified study data.
- Jurisdiction
- International
- Stage
- Close-out
First-page preview · request required for download
Clinical trial templates
Results disclosure and publication plan
Track applicable reporting and dissemination commitments.
- Jurisdiction
- International
- Stage
- Close-out
First-page preview · request required for download
Document bundles
Planning document bundle
A coordinated set of 10 planning working templates with completion guidance. Each document needs study-specific adaptation and review.
- Jurisdiction
- International
- Stage
- Planning
First-page preview · request required for download
Document bundles
Study start-up document bundle
A coordinated set of 11 startup working templates with completion guidance. Each document needs study-specific adaptation and review.
- Jurisdiction
- International
- Stage
- Study start-up
First-page preview · request required for download
Document bundles
Study conduct document bundle
A coordinated set of 16 conduct working templates with completion guidance. Each document needs study-specific adaptation and review.
- Jurisdiction
- International
- Stage
- Study conduct
First-page preview · request required for download
Document bundles
Study close-out document bundle
A coordinated set of 5 closeout working templates with completion guidance. Each document needs study-specific adaptation and review.
- Jurisdiction
- International
- Stage
- Close-out
First-page preview · request required for download
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