01
Administrative Prerequisite
Application Letter
A formal letter of application addressed to the BUHREC Chairman, channeled through the academic supervisor. The letter must bear the supervisor’s physical signature and the official departmental office stamp before proposal submission.
02
Word Count Threshold
Study Title (Max 24 Words)
Concise, informative description of the study. Strict institutional length rules apply: 18 words is the recommended standard; 22 words may be acceptable; under no circumstance may it exceed 24 words.
03
Chapter 1 Foundation
Introduction & Background
Comprehensive background information contextualizing the research problem, explicit description of the study, experimental devices, animals, laboratory assays, or human observational settings.
04
Research Aim
Objectives & Hypotheses
Clearly articulated primary, secondary, and tertiary objectives. Where applicable, hypotheses and corresponding research questions must be explicitly structured to match analytical tests.
05
Scholarly Evidence
Literature Review
Critical synthesis of peer-reviewed literature published in reputable professional journals or academic books. Must articulate current knowledge, identify evidential gaps, and justify the ethical necessity of the new investigation.
06
Design & Execution
Methodology & Study Design
Detailed operational design specifying where and how the study will be conducted, recruitment strategy for human participants, sample size calculation, statistical power, and total study duration.
07
Cohort Demarcation
Study Population & Eligibility
Rigorous definition of who qualifies for recruitment:
• Inclusion Criteria: Age ranges, confirmed disease type, clinical presentation.
• Exclusion Criteria: Vulnerable groups, conflicting medical history, ongoing medication.
08
Clinical / Laboratory
Study Product / Device
(Where applicable): Therapeutic regimen, dosage, route and mode of administration, formulation details, supply chain provenance, dispensing accountability, and permitted or prohibited concomitant agents.
09
Trial Operations
Study Procedures & Specimens
(Where applicable): Participant enrollment and informed consent protocols, clinical and follow-up visit schedules, orderly exit protocols, biological specimen collection, biosafety handling, and disposal protocols.
10
Safety Surveillance
Assessment of Safety
(Where applicable): Real-time safety monitoring committee protocols, independent clinical data reviews, vital signs thresholds, and long-term participant follow-up mechanisms after study conclusion.
11
Adverse Events
Clinical Management & AE
(Where applicable): Standard definitions of adverse events (AE/SAE), escalation pathways, when and how to modify oral doses, criteria for discontinuing a participant or product, and immediate medical emergency care.
12
Data Governance
Statistics & Data Safety
Complete analytical plan detailing statistical formulae, tools (SPSS, R, STATA), data security architectures, secure archiving, de-identification/anonymization codes, and participant confidentiality agreements.
13
Appendices & Instruments
References, Consent Form & Data Instruments
The submission binder must culminate in:
• Complete, standard-formatted List of References citing professional peer-reviewed publications.
• Official Informed Consent Form satisfying all 13 elements of the BUHREC Checklist (see verification tool below).
• Complete Instruments for Data Collection (questionnaires, interview rubrics, clinical proformas) bound in the appendix.