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.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

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Dealing with Challenging Clients

1. The Creeping (Scope Creep) Client
The creeping attack is characterized by an initial agreement to implement a set of agreed upon features by a series of repeated requests for new functionality and additions that were never discussed.

2. The Low Ball Client
The single minded focus on the price of the project right from the beginning.

3. The Octopus Client
This is characterized by micromanagement. The many hands of the octopus reach in and try to control every aspect of the project, effectively overriding your judgements and experience.

4. Attack of Urgency Client
It is characterized by a series of blindingly fast requests that you are expected to deal with at a moments notice.

Choose a job you love, and you will never have to work a day in your life.

5. Hands On Hands Off Client
This consists of the client doing or saying very little if anything at all. With no feedback to go by, good or bad, the freelancer is more less left to make best guess and hope it sticks.

6. Golden Peacock Client
This client essentially dazzle you with “you should be lucky to work for this client or company for this project ABC” so you work for next to nothing for the glory of working on the project in the first place.

7. The Extortionist Client
It is one that you don’t ever want to deal with. Essentially, this client uses money to control you and don’t pay services on time.

8. Crouching Tiger Client
Essentially the client baits the freelancer with the promise of future riches and success if they are willing to take a hit now and wait and give the client the sale of the century on this project.

9. The Dream Client
They are rare but they do exist. They pay on time, express appreciation for your work, treat you with respect and they have realistic expectations and timelines.

Source: appBuilderTV.com

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.

anayansi gamboa

Oracle Clinical (OC) Cheat Sheet

OC Shortcuts

Code Description
Space Bar Check or uncheck Checkbox
CRTL+Q Back up to last screen and/or Exit
F3 Copy data from row above
F6 Insert new record below
F7 Enter into Query mode
F8 Execute Query
F9 List of Values (LOV) for entry
F10 Save
ROUND ROUND(number,precision) – Rounds number to the decimal value determined in the precision parameter
e.g. ROUND(BMI,1)
TRUNC TRUNC(number) – Removes decimal places from number
e.g. TRUNC(WEIGHT)
NVL NVL(string,’value if null’) – Returns specified value if string is null
e.g. NVL(VITALS.VISITDT,’01’)
DECODE DECODE(expression,value1, return1, value2, return2,,,,,, default) – Functions as an inline if statement. If the expression results in value 1, then report return1, and so on. If no values are found function returns the default.e.g. DECODE(VISIT_NO,10,20,30,40,50,88,99)
UPPER/LOWER UPPER(string) / LOWER(string) – Sets string to all uppercase or lowercase
e.g. UPPER(AETERM)
LOWER(AETERM)
LENGTH LENGTH(string) – Returns an integer value of the length of the value of the string
e.g. LENGTH(ENROLL.RANDOMNO) < 6

Source: OC User Manual