Clinical data management<br />Made by:-<br />ShrayJali<br />
Clinical data<br /><ul><li>Most valuable asset to a pharmaceutical company
Serves as a basis for submission, approval, labelling and marketing of a compound
Sources:
Subject-investigator interaction at sites (e.g. Remote Data Capture (RDC) technology)
Laboratories
Directly from subjects and partners </li></ul>(e.g. Contract Research Organizations - CROs)<br />
Clinical trials<br /><ul><li>Conducted to allow safety and efficacy data to be collected for new drugs or devices
Health Authority/Ethics Committee approval is necessary
Often a clinical trial is managed by an outsourced partner such as a CRO
Includes measurements like vital signs, amount of study drug in the blood, and whether the patient's health gets better or...
Clinical data management<br /><ul><li>Used in clinical research to manage the data of a clinical trial
Clinical trial data gathered at the investigator site in the case report form are stored in the CDMS
To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry such as dou...
Standard dictionaries of these terms can be loaded into the CDMS
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Clinical Data Management

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Clinical Data Management

  1. 1. Clinical data management<br />Made by:-<br />ShrayJali<br />
  2. 2. Clinical data<br /><ul><li>Most valuable asset to a pharmaceutical company
  3. 3. Serves as a basis for submission, approval, labelling and marketing of a compound
  4. 4. Sources:
  5. 5. Subject-investigator interaction at sites (e.g. Remote Data Capture (RDC) technology)
  6. 6. Laboratories
  7. 7. Directly from subjects and partners </li></ul>(e.g. Contract Research Organizations - CROs)<br />
  8. 8. Clinical trials<br /><ul><li>Conducted to allow safety and efficacy data to be collected for new drugs or devices
  9. 9. Health Authority/Ethics Committee approval is necessary
  10. 10. Often a clinical trial is managed by an outsourced partner such as a CRO
  11. 11. Includes measurements like vital signs, amount of study drug in the blood, and whether the patient's health gets better or not & then the data is sent to the trial sponsor who analyses the pooled data using statistical tests</li></li></ul><li>Clinical trials<br />
  12. 12. Clinical data management<br /><ul><li>Used in clinical research to manage the data of a clinical trial
  13. 13. Clinical trial data gathered at the investigator site in the case report form are stored in the CDMS
  14. 14. To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry such as double data entry</li></li></ul><li>Clinical data management<br /><ul><li>Coding of data: adverse event terms and medication names
  15. 15. Standard dictionaries of these terms can be loaded into the CDMS
  16. 16. Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct term</li></ul>Example: ASA could be mapped to Aspirin<br />
  17. 17. Clinical data management<br /><ul><li>Data gathered during clinical trials is stored within a CDMS
  18. 18. Ensures that human error will be kept to a minimum
  19. 19. Software systems of this type also file data and screen data for any illogical patterns
  20. 20. Helps researchers to scrutinize their material. Clinical software has largely replaced manual inputting of data. Most programs of this type include spreadsheet</li></li></ul><li>Clinical data management<br />
  21. 21. double data entry<br /><ul><li>Method of quality control, very useful in catching and correcting typographical errors
  22. 22. Also known as Two pass verification</li></ul>Special features of our Double Keyed Data Entry Service:<br /><ul><li>High accuracy
  23. 23. High data security
  24. 24. Affordable rates
  25. 25. Efficient validation procedures
  26. 26. Advanced technology
  27. 27. Flexibility
  28. 28. Duplicate check identification</li></li></ul><li>Dictionary management<br /><ul><li>Stores the structure of the structure of the clinical data tables so that they can be accessed correctly
  29. 29. Also known as metadata (Data table restricted to information about data elements) repository
  30. 30. e.g. MedDRAfor adverse events and WHO Drug for medications </li></li></ul><li>Dictionary management<br />
  31. 31. Clinical database search<br />
  32. 32. Dictionary management<br />
  33. 33. Need for cdms<br /><ul><li>To find ways to cut both costs and time from the clinical development process
  34. 34. Get an accurate, real-time view of clinical trial forecasts and budgets
  35. 35. Effectively use critical information and collaboratively assess performance.
  36. 36. Aggregation of data and its Dissemination via an open framework
  37. 37. To limit error, improve control, enhance visibility, and boost accountability</li></li></ul><li>

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