| A clinical trial is a clinical research which involves | | | | inspection long after the actual study is completed. |
| controlled test of the new drugs or 'new invasive | | | | The documentation in clinical trials also has some |
| medical device' on human beings and is conducted | | | | directly related function as based on it the future |
| under the regulatory acts of the FDA before it is | | | | planning, tracking and execution is done in the |
| made available for general public use or general | | | | research-oriented work. The process of |
| clinical use. These clinical trials are mainly | | | | documentation related to the clinical trial involves |
| conducted to allow safety of the data to be | | | | certain rules and regulations set by the regulatory |
| collected for health related studies involving | | | | body of the country -for e.g. which in the case of |
| therapy protocols or related to the introduction of | | | | US is the FDA. The quality of data produced and |
| new drugs in the medical market of a particular | | | | kept in the clinical documentation should meet the |
| country only after a certain regulatory body has | | | | standards. There are certain rules to follow in |
| approved of it. The clinical documentation comes | | | | storing and maintaining the data as well. There are |
| in very handy in these cases as it helps to keep | | | | other regulatory body as well who decides on the |
| in-detailed record of each happening. The clinical | | | | types of documentation for each case. |
| trials can cover a wide range of subjects and can | | | | In case of the clinical trial, some of the important |
| vary in size to one centre in a country to many | | | | documents are the case record forms, informed |
| centres in multiple countries. | | | | consent forms, protocol, investigators brochure |
| Since the clinical trials are research-based work, | | | | and the patient information sheet- all of which |
| clinical documentation plays an important role in it | | | | follow very stringent rules ad principle that are to |
| and forms an integral part of the clinical research. | | | | be followed. Some of the rules for clinical |
| The proper documentation helps to keep proper | | | | documentation are as follows: |
| track of what is happening and is important from | | | | - Labelling of all the documents along with the |
| the pre-clinical studies and updates documentations | | | | date, which should be clearly visible. |
| are of utmost importance in the total process of | | | | - The documents are to be arranged so that |
| clinical trial. The clinical documentation is needs to | | | | they are fully reconstructable even after the |
| capture and attest the data collected and the | | | | study is completed. |
| authenticity of the data and its use in the clinical | | | | - All the documentations should follow the |
| trial. The documentation is generally preserved | | | | guidelines provided by the regulatory authorities |
| and helps in future reference and may help in | | | | strictly and there should be no discrepancies. |