Improving Clinical Data: An important Step in Clinical Research

Improving Clinical Data: An important Step in Clinical Research

Clinical Research is an important field, where in Researchers work on various new drug molecules and establishes its efficacy and safety.  The major point to note here is that for efficacy and safety parameters data must be accurate and clean. If the data is not validated and accurate then it may have false results. Improving study data is critical and it should be done very carefully. The methods to do data cleaning include following

1. As we record patients data on CRF, so It is important that the data entered must be from source document and it’s the data must be
   1. Clean
   2. Clear
   3. Accurate
2. The CRF should be filled with black ball point pen and there should not be white fluid usage.
3. In any case, If there is an error in data entry, then single line cut along with accurate data should be there
4. You should fill Not Available/Unknown at appropriate places
5. When transferring data to Statistical Software, it should be done correctly and it is important that
   1. SPSS/SAS data should be clean and accurate
   2. All units must be in harmony and homogenous with each other.
   3. There should not be any empty spaces
   4. Decimal should be placed at correct place
6. Another important point is traceability, Which means tracking the data so that it is correct and it matches source document also,

If we follow ICH-GCP guidelines, protocol, New CT rules, Standard Operating Procedures and other applicable regulatory guidelines with utmost care then we can say that data of our clinical trial has been recorded and reported accurately.

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