Treatment Trials Program

Application Process

The treatment trial application consists of 7 parts submitted online:

#### Part 1: Investigators
1. List Principal Investigator (PI) with:
- Salutation, first name, middle name, last name
- Job title
- Department
- Institution name and address
- Phone, fax, email
- Degrees
2. List all co-investigators (up to 5 additional co-investigators) with same information
3. Required attachments: CVs for PI and all co-PIs (not to exceed 5 pages each)

#### Part 2: Treatment Trial Details
1. Fill in the following required fields:
- Title of Proposed Treatment Trial
- Primary Drug and Dose (required)
- Secondary Drug and Dose (if any)
- Target Population (required): Select from Schizophrenia or Bipolar Disorder
- Total Sample Size (required)
- Study Period for Each Subject (in days, required)
- Length of Entire Trial (in years, required): Choose One Year, Two Years, or Three Years
- Study Design (e.g., double blind, crossover, etc.)

#### Part 3: Abstract and Proposal
1. Abstract (500 words or less, including spaces):
- Copy and paste abstract into text field
- Optional: Attach charts/graphs via Media Upload

2. Proposal Summary (approximately 5 pages, required):
- Include the following elements:
a) Scientific rationale for the study, citing relevant basic research and prior clinical experience with the drug
b) Detailed study design including outcome measurements
c) Description of how compounds will be obtained
- Copy and paste summary into text field
- Figures and tables should be limited to 1-2 figures per application
- Optional: Attach charts/graphs via Media Upload

#### Part 4: Blood Brain Barrier
1. Answer: "Does this compound cross the blood brain barrier?" (Yes/No)
2. Provide explanation (no character limit):
- If YES: Brief explanation of supporting data that it crosses the blood brain barrier
- If NO: Explain why the compound will be helpful for treating schizophrenia or bipolar disorder

#### Part 5: References and Attachments
1. List of references (not to exceed 5 pages):
- Upload as attachment
2. CVs attachment section:
- PI CV (not to exceed 5 pages)
- Co-PI CVs (not to exceed 5 pages each)
3. Figures/charts attachment section:
- Limited to 1-2 figures per application

#### Part 6: Budget Items
1. Provide line-by-line budget items:
- All figures in U.S. dollars
- Specify for each item:
- Category: Personnel/Salary, Patient Costs, Supplies, Equipment, or Other
- Item Name
- Item Amount
2. Personnel/Salary costs: List individually for each person
3. Other items: May be grouped by category
4. Indirect costs: May include up to 15% of total costs
5. Total Amount Requested
6. Note: If additional detail needed, review panel will request it
7. Consultant Assistance: If requesting SMRI consultant help (for trial design, CRF development, data management, statistical analysis, etc.), do NOT include cost—SMRI will add estimated cost

#### Part 7: Funding Sources and IRB Approval Status
1. List all funding sources (pending and secured):
- Related to proposed research
- Other than proposed SMRI funding
- Clearly note if funding is "pending" or "secured"

2. IRB (Ethical) Approval Status (check appropriate box):
- Received (already have approval)
- Pending (approval in process)
- Will apply when grant application is approved for funding
- Note: IRB approval NOT required before submission, but must be provided before funding is released

#### Final Steps
1. Review entire application
2. Option to print application
3. Click "Submit Application" to enter into review system
4. Important: Only applications marked as "submitted" from your account will be reviewed

Application Assistance

SMRI offers no-cost consultant support for approved applicants in the following areas:

Optimal trial design

Inclusion and exclusion criteria for patient selection

Clinical report form (CRF) development

Data management (including possibility of SMRI central data entry)

Dropout data evaluation

Statistical analysis

Indicate on application if consultant assistance desired upon funding approval.