Tag Archives: Project planning

The Greater Israel Project: Fireworks May Indicate US/Israeli Intelligence Operation to Burn US Cities to the Ground

There have been nationwide reports of wide-scale fireworks use in major cities that NEVER experienced either the importation of fireworks into them or any tradition of their use. Police intelligence units appear to be “standing down” and allowing this extremely unusual activity. This playbook appears to be mirroring the great fire of London occurring after the winding down of the great plague of London.

The RICH are going to do an INSURANCE job. Remember 911, Larry A. Silverstein insured the Twin Towers just two months prior to their falling on their footprints. The insurance was about ‘terrorists’. How a coincidence is that? How Larry Silverstein will know that the Twin Towers will be attached by terrorists? The same will happen this year. The RICH are ensuring their businesses against fires that they planning to unleash on several US cities thru their organization called “Black Life Matters and Anifa”.

Source:

Helen of Destroy

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Data Management Plan in Clinical Trials

 

The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning.

The data management plan typically contains the following items. They are:

  1. Introduction/Purpose of the document
  2. Scope of application/Definitions
  3. Abbreviations
  4. Who/what/where/when
  5. Project Schedule/Major Project Milestones
  6. Updates of the DMP
  7. Appendix

The objective of this guidelines is to define the general content of the Data Management Plan (DMP) and the procedures for developing and maintaining this document.

The abbreviation section could include all acronyms used within a particular study for further clarification.

e.g. CRF = Case Report Form
TA = Therapeutic Area

The Who/What/Where/When section should describe the objective of the study specific data management plans for ABC study. This section provides detail information about the indications, the number of subjects planned for the study, countries participating in the clinical trial, monitoring guidelines (SDV) or partial SDV, if any CROs or 3rd party are involved in the study (e.g. IVRS, central labs), which database will be used to collect study information (e.g. Clintrial, Oracle Clinical, Medidata Rave or Inform EDC).

The Appendix provides a place to put supporting information, allowing the body of the DMP to be kept concise and at more summary levels. For example, you could document Database Access of team members, Self-evident correction plan, Data Entry plan if using Double-data entry systems or Paper-Based clinical trials systems.

Remember, this is a living document and must be updated throughout the course of the clinical trial.

If problems arise during the life of a project, our first hunch would be that the project was not properly planned.

Reference: Role of Project Management in Clinical Trials
Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

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