- ISBN: 9780471929413 | 0471929417
- Cover: Hardcover
- Copyright: 6/1/1991
| Cut Costs and Increase Profits | |
| No Excuse for the Wastage | |
| Front-Loaded Solution | |
| Downsizing | |
| Think Transnational | |
| A Final Word | |
| Guidelines | |
| Start with Your Reports | |
| The Wrong Way | |
| Keep It in the Computer | |
| Don't Push the River | |
| Kiss | |
| Plug the Holes as They Arise | |
| Pay for Results, Not Intentions | |
| Plan, Do, Then Check | |
| Plan | |
| Prescription for Success | |
| Plan | |
| Predesign Phase | |
| Design the Trials Do | |
| Obtain Regulatory Agency Approval for the Trials | |
| Form the Implementation Team | |
| Line Up Your Panel of Physicians | |
| Develop the Data Entry Software | |
| Test the Software | |
| Train | |
| Recruit Patients | |
| Set Up External Review Committee | |
| Conduct the Trials | |
| Develop Suite of Programs for Use in Data Analysis | |
| Analyze and Interpret the Data Check | |
| Complete the Submission | |
| Staffing for Success | |
| The People You Need | |
| Design Team | |
| Obtain Regulatory Approval for the Trials | |
| Track Progress | |
| Implementation Team | |
| Develop Data Entry Software | |
| Test the Software | |
| Line Up Your Panel of Physicians | |
| External Laboratories | |
| Site Coordinators | |
| External Review Committees | |
| Recruit and Enroll Patients | |
| Transnational Trials | |
| Conduct the Trials | |
| Programs for Data Analysis | |
| Analyze and Interpret the Data | |
| The People You Don't Need | |
| For Further Information | |
| Design Decisions | |
| Should the Study Be Performed? | |
| Should the Trials Be Transnational? | |
| Study Objectives | |
| End Points | |
| Secondary End Points | |
| Should We Proceed with a Full-Scale Trial? | |
| Tertiary End Points | |
| Baseline Data | |
| Who Will Collect the Data? | |
| Quality Control | |
| Study Population | |
| Timing | |
| Closure | |
| Planned Closure | |
| Unplanned Closure | |
| Be Defensive | |
| Review, Rewrite, Review Again | |
| Checklist for Design | |
| Budgets and Expenditures | |
| For Further Information | |
| Trial Design | |
| Baseline Measurements | |
| Controlled Randomized Clinical Trials | |
| Randomized Trials | |
| Blocked Randomization | |
| Stratified Randomization | |
| Single- vs. Double-Blind Studies | |
| Allocation Concealment | |
| Exceptions to the Rule | |
| Sample Size | |
| Which Formula? | |
| Precision of Estimates | |
| Bounding Type I and Type II Errors | |
| Equivalence | |
| Software | |
| Subsamples | |
| Loss Adjustment | |
| Number of Treatment Sites | |
| Alternate Designs | |
| Taking Cost into Consideration | |
| For Further Information | |
| Exception Handling | |
| Patient Related | |
| Missed Doses | |
| Missed Appointments | |
| Noncompliance | |
| Adverse Reactions | |
| Reporting Adverse Events | |
| When Do You Crack the Code? | |
| Investigator Related | |
| Lagging Recruitment | |
| Protocol Deviations | |
| Site-Specific Problems | |
| Closure | |
| Intent to Treat | |
| Is Your Planning Complete? | |
| DO | |
| Documentation | |
| Guidelines | |
| Common Technical Document | |
| Reporting Adverse Events | |
| Initial Submission to the Regulatory Agency | |
| Sponsor Data | |
| Justifying the Study | |
| Objectives | |
| Patient Selection | |
| Treatment Plan | |
| Outcome Measures and Evaluation | |
| Procedures | |
| Clinical Follow-Up | |
| Adverse Events | |
| Data Management, Monitoring, Quality Control | |
| Statistical Analysis | |
| Investigator Responsibilities | |
| Ethical and Regulatory Considerations | |
| Study Committees | |
| Appendixes | |
| Sample Informed Consent Form | |
| Procedures Manuals | |
| Physician's Procedures Manual | |
| Laboratory Guidelines | |
| Interim Reports | |
| Enrollment Report | |
| Data in Hand | |
| Adverse Event Report | |
| Annotated Abstract | |
| Final Reports(s) | |
| Regulatory Agency Submissions.e-Subs | |
| Journal Articles | |
| For Further Information | |
| Recruiting and Retaining Patients and Physicians | |
| Selecting Your Clinical Sites | |
| Recruiting Ph | |
| Table of Contents provided by Publisher. All Rights Reserved. |
What is included with this book?
The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.
The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.
Please wait while the item is added to your bag...
×
Digital License
You are licensing a digital product for a set duration. Durations are set forth in the product description, with "Lifetime" typically meaning five (5) years of online access and permanent download to a supported device. All licenses are non-transferable.
More details can be found here.