# Experimental Plan Template (Pre-Registration Style) ## 1. Study Information **Title:** [Descriptive title] **Authors:** [Names] **Date:** [Pre-registration date] **Version:** [1.0] ## 2. Research Questions & Hypotheses **Primary research question:** [What is the main question this study answers?] **Hypotheses:** - H₀ (null): [Statement of no effect] - H₁ (alternative): [Statement of expected effect] **Secondary questions:** [1-3 additional questions, if any] **Exploratory questions:** [Questions without directional predictions] ## 3. Design **Design type:** [ ] Randomized experiment [ ] Quasi-experiment [ ] Observational study [ ] Other: ______ **Design specification:** [ ] CRD [ ] RCBD [ ] Factorial [ ] Crossover [ ] Longitudinal [ ] Case-control [ ] Cohort **Randomization unit:** [ ] Individual [ ] Cluster [ ] Block [ ] Other: ______ **Analysis unit:** [Same as randomization unit, or specify if different] **Blinding:** [ ] None [ ] Single-blind [ ] Double-blind ## 4. Sample Size / Power **Power analysis parameters:** | Parameter | Value | Source | |-----------|-------|--------| | α (Type I error) | 0.05 | Convention | | Power (1 − β) | 0.80 | Convention | | Expected effect size | [value and metric] | [prior study, pilot, or MDE] | | Minimum detectable effect | [value] | [computed] | | Required sample size (total) | [N] | [computed] | | Attrition adjustment | [additional N] | [expected dropout rate] | | **Final target N** | **[N]** | | **Power analysis output:** [Attach or reference the power analysis script output] ## 5. Participants / Subjects **Target population:** [Who/what are we studying?] **Inclusion criteria:** 1. [Criterion 1] 2. [Criterion 2] **Exclusion criteria:** 1. [Criterion 1] 2. [Criterion 2] **Recruitment:** [How will participants be identified and recruited?] **Assignment:** [How will participants be assigned to conditions?] ## 6. Variables ### Primary Outcome | Variable | Definition | Measurement | Type | |----------|------------|-------------|------| | [name] | [operational definition] | [instrument, units] | [continuous/binary/time-to-event] | ### Secondary Outcomes | Variable | Definition | Measurement | Type | |----------|------------|-------------|------| | [name] | | | | ### Predictors / Treatments | Variable | Levels | Assignment | Notes | |----------|--------|------------|-------| | [name] | [level1, level2, ...] | [randomized/observed] | | ### Covariates (pre-registered) | Variable | Rationale | |----------|-----------| | [name] | [why this variable is included] | ## 7. Procedure **Timeline:** | Phase | Activity | Duration | |-------|----------|----------| | 1 | Recruitment | [time] | | 2 | Pre-treatment measurement | [time] | | 3 | Treatment administration | [time] | | 4 | Post-treatment measurement | [time] | | 5 | Follow-up | [time] | **Detailed protocol:** [Step-by-step description of what happens to each participant] ## 8. Analysis Plan ### Primary Analysis **Method:** [e.g., Independent t-test, linear regression, ANCOVA] **Model specification:** [e.g., outcome ~ treatment + covariate1] **Assumptions to be checked:** | Assumption | Diagnostic | Remediation If Violated | |------------|------------|------------------------| | Normality | Shapiro-Wilk, Q-Q plot | Transform data or use nonparametric test | | Equal variance | Levene's test | Welch's correction | | Independence | Durbin-Watson | GLS / mixed model | | [other] | [method] | [alternative] | ### Secondary Analyses [Method for each secondary question] ### Exploratory Analyses [Methods for exploratory questions] ### Subgroup Analyses (pre-specified) | Subgroup | Rationale | |----------|-----------| | [group] | [why this subgroup might differ] | ### Missing Data Handling **Expected missingness:** [Amount and pattern expected] **Primary approach:** [ ] Complete case analysis [ ] Multiple imputation [ ] Maximum likelihood [ ] Last observation carried forward [ ] Other: ______ ### Multiple Testing **Correction method:** [ ] Bonferroni [ ] Holm [ ] Benjamini-Hochberg [ ] None (confirmatory study with single primary outcome) [ ] Other: ______ **Number of comparisons:** [ ] ## 9. Data Collection & Management **Data collection tools:** [ ] Survey platform [ ] Lab equipment [ ] Administrative records [ ] Other: ______ **Data storage:** [How and where will data be stored?] **Quality control:** [Checks for data quality during collection] ## 10. Ethics & Reporting **Ethics approval:** [ ] Obtained (IRB #: ______) [ ] Pending [ ] Not required **Consent:** [ ] Written [ ] Verbal [ ] Waived **Conflicts of interest:** [None / describe] **Data availability:** [Where will data and code be posted?] ## 11. Changes from Original Plan [If this is an update to a pre-registration, document any changes here with date and rationale]