Research Tools
Guidelines on Clinical Research Protocol Preparation
All clinical research should be based on a scientifically sound, clear, and detailed protocol. The protocol should be reviewed and approved by the Clinical Research Ethics Committee before the commencement of the study.
Generally, a clinical research protocol should include:
- Study Title
- Short Summary of the Study
- Rationale
- Background Information
- Study Objectives
- Hypothesis
- Methodology
- Statistical Considerations
Guidelines on Informed Consent Form Preparation
Freely given informed consent is required for from each study subject prior to study participation. Informed consents are ususally obtained with the use of Informed Consent Forms (ICF). All ICFs should be reviewed and approved by the Clinical Research Ethics Committee prior to use.
According to ICH-GCP, an Inform Consent Form should explain:
- Purpose of the Study
- Trial Treatment and Randomization
- Trial Procedures and Expected Duration
- Experimental Aspect
- Benefits, Risks, and Inconveniences
- Alternative Treatments
- Payment and Expenses
- Participation is Voluntary
- Contact Information of Study Team
Sample Size Estimation and Statistical Power Analyses - G*Power Program
G*Power is tool to compute statistical power analyses for many different t tests, F tests, χ2 tests, z tests and some exact tests. G*Power can also be used to compute effect sizes and to display graphically the results of power analyses.
G*Power can be downloaded and used without any charge for academic use.
eCRF Service - REDCap Consortium
REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), it is specifically geared to support online and offline data capture for research studies and operations.
REDCap can be downloaded for free for academic use.