| The clinical documentation improvement program | | | | reviewed annually in compliance with the latest |
| industry has become one of the most expanding | | | | standards of the regulatory bodies of the country. |
| industries due to the recent advancements made in | | | | While clinical documentation improvement program, |
| the fields of biotechnology. So it is of utmost | | | | the clinical study protocol must have the records of |
| important to make the data simple and objective as | | | | the adequate data collection, analysis and conduction |
| it will mainly relate to the clinical and pre-clinical | | | | of the data related to the clinical trial for further |
| investigational drug. It is very important for the | | | | review and research purposes. Another important |
| documentation to include the brief description of the | | | | part of the documentation is the informed consent |
| pharmaceutical properties of the of the product for | | | | as it ensures the ethics of the clinical trial. This is very |
| clinical trial which will include all the details of the | | | | important as the person confirms that he is |
| generic and the trade names of the products to be | | | | voluntarily participating in the clinical trial and is aware |
| introduced in the country in accordance with the rules | | | | and informed of the details and this he has to sign |
| and regulations of the governing body. | | | | along with the date. He should be informed |
| The clinical documentation improvement program of | | | | thoroughly of the objectives and the methods |
| the clinical trials should include all the details of the | | | | involved along with the potential risks and benefits in |
| pharmacological, metabolic, therapeutic and any | | | | the procedure. |
| relevant details of the new drug like the physical and | | | | Similar to the clinical study protocol, is the case |
| the chemical properties as well. The clinical | | | | record form that is also called the CRF- this is an |
| documentation improvement program should be able | | | | electronic document that will record all information for |
| to provide an overall general approach that can be | | | | an individual study and is needed to ensure that the |
| used in evaluating the product. The important | | | | regulatory bodies' rules are followed in data collection |
| documentations in the clinical trial includes the | | | | thus facilitating accurate data analysis and should |
| investigator's brochure, subject information, consent | | | | include all demographic data. clinical documentation |
| form, clinical study reports, lab analysis reports, case | | | | improvement program will involve safety reporting |
| report forms, references- if any, the investigators' | | | | which is very important and should also record any |
| conclusion and most importantly the clinical study | | | | adverse events or any abnormal lab test values or of |
| protocol. Normally the investigators' brochure is | | | | any safety parameters as well. |