A broad spectrum of site training is available. We have the training you need to run successful clinical studies, whether you are just beginning work in research or have specific areas that need improvement or reorganization.

Starting a Study

  • Set up for the Sponsor's Site Visit
  • Handling of Informed Consents
  • Corresponding with the Institutional Review Board (IRB)
  • Study File set up
  • GCP review

Preparing for a Study - Initiation Visit

  • Recruiting Subjects
  • Gathering and Recording Data
  • Source Documents
  • Case Report Form
  • Adverse Events
  • Monitoring Visits
  • Investigative Drug Management
  • GCP Review

Closing a Study - Analyzing a Protocol

  • Protocol Analysis
  • Recruitment considerations
  • Budget concerns
  • Ethical Considerations
  • "Fit" With Site

Mastering Study Budgets

  • Budget Preparation
  • Contingency Plan Preparation
  • Negotiating with Sponsors
  • Budget Management

Dealing with Ethical Issues

  • The Belmont Report
  • Ethical Principles
  • Practice vs. Research

Understanding ICH Guidelines*

  • Compare/Contrast to FDA

Preparing for an FDA Audit

  • Audit types
  • The Inspection: What to Expect
  • Common results and Follow-up Procedures

Improving Productivity

  • Time Management Tips

Creation and Use of Clinical Trial Financial Reports

  • Planning Financial Status Reports
  • Planning Financial Projection Reports
  • Single Study Financial Report Example
  • Multi-Study Financial Report
  • Collecting the Data

Financial Analysis of a Protocol

  • Defining Team Member Rolls at Your Site
  • Protocol Analysis Process
  • Analyzing the Protocol for Study Events
  • Determining the Cost of Each Study Event

Drafting the Subject Budget

  • Study Budget Drafting
  • Line Items
  • Finalizing the Study Budget

Negotiating the Contract

  • The Effect of the Contract on Study Finances
  • How to Prepare to Negotiate the Contract
  • Contract Vocabulary
  • Contract Payment Schedule Analysis
  • Negotiating the Contract Terms

Tracking Study Activity

  • Tracking Activity
  • Tracking Subject Activity
  • Expanding the Database of Subjects
  • Subject Activity Reports

Securing Sponsor Payments

  • Preparing Billing Information
  • Billing to the Sponsor
  • Income Reports

Accurate Expense Payments

  • Expense Information Organization
  • Expense Verification & Vendor Payment
  • Special Issues with Expenses and 3rd Party Vendors
  • Paying Research Subjects
  • Expense Report Completion

Helpful Site Information

  • Troubleshooting
  • Analyzing the Success of the Clinical Trial
  • Information storage