Life & Health Sciences
Clinical Medicine & Healthcare
Research conducted in clinical and healthcare delivery settings, including interventional trials, observational studies, and health-services research. This sector carries obligations that purely laboratory research does not: informed consent, ICH GCP compliance, trial registration, adverse-event reporting, HIPAA and privacy protections, and clinical-trial billing compliance. Guidance tagged here addresses both the investigator and the coordinating/administrative staff.
11 pages across 7 topic areas
Laboratory Compliance & Quality
- Lab Waste Disposal: RCRA Streams, Generator Status, and Disposal Routes
A research lab generates several legally distinct waste streams — RCRA hazardous chemicals, medical/biohazardous waste, sharps, radiological waste, an…
- Proficiency Testing & External Quality Assessment (EQA) for Accredited Labs
How proficiency testing (PT) and external quality assessment (EQA) schemes work under ISO/IEC 17043 and CLIA, including how PT samples must be handled…
- CLIA Certification: Certificate Types, Complexity Categories, and Whether Your Lab Needs One
A guide to CLIA certification under 42 CFR Part 493: the five certificate types, waived/moderate/high complexity categories, and the research-lab exem…
Laboratory Equipment & Instrumentation
- Pipette Tips: Selection Guide by Application
How to choose pipette tips by application: filter/barrier vs. standard, low-retention vs. standard, sterile vs. autoclavable, and rack vs. bulk format…
- Biosafety Cabinet vs. Fume Hood vs. Laminar Flow Hood: Which Do You Need?
Research Tools & Software
- What Is a LIMS? Laboratory Information Management System Explained
A Laboratory Information Management System (LIMS) tracks lab samples, workflows, and results with a full audit trail. This guide explains what a LIMS …
- Covidence vs. Rayyan vs. DistillerSR: Systematic Review Software Compared
Clinical Research Administration
- 21 CFR: What Title 21 of the Code of Federal Regulations Covers
A routing guide to Title 21 of the Code of Federal Regulations: how CFR citations are structured, and which Part governs electronic records, informed …
Research Integrity & Compliance
- 45 CFR 46 and the Common Rule: What Each Subpart Covers
45 CFR 46 is the HHS human-subjects regulation with five subparts (A-E). The Common Rule is specifically Subpart A. This guide maps every subpart to i…
Scholarly Publishing
- The EQUATOR Network: Which Reporting Guideline Does Your Study Need?
A study-design routing table for the EQUATOR Network’s reporting guideline library — CONSORT, PRISMA, STROBE, SPIRIT, STARD, TRIPOD, ARRIVE, SQUIRE, C…
Research Methods & Statistics
- Power Analysis and Sample Size Calculation: A Complete Guide
How to run a power analysis to calculate sample size: the four interlocking quantities (effect size, alpha, power, N), a priori vs. post-hoc power, ch…
