| The clinical data management is an integral part of | | | | 1. Paper based data. |
| a CRO. This unit is responsible for the accurate | | | | 2. Electronic data. |
| collection and scientific validation of the data | | | | The data received from the site could be |
| produced from the trials. They provide the | | | | completely paper based or could be both paper |
| "cleaned" results to the statisticians. This will help | | | | based and electronic. Generally paper based data |
| the statisticians to analyse the results and | | | | will be CRFs and electronic data will be lab reports. |
| determine the outcome of the trials and decide if | | | | The data base should be design should provide |
| the results can be published and if the drug can | | | | the provision for both manual entry and electronic |
| be marketed or not. | | | | data capture of the data. |
| The Process | | | | The principles for designing a database: |
| The unit must ensure the quality of the data | | | | 1. The database should be secure. Different levels |
| generated, to avoid the expensive process of | | | | of access must be set |
| corrections and querying. The process has the | | | | 2. Standards should be applied for the database |
| following parts to ensure that the data gathered | | | | content. |
| is of highest quality and the trial is completed | | | | 3. Database must allow the editing of the entered |
| successfully. | | | | content and contain audit trails for all the edits and |
| 1. Planning a Trial | | | | retain the original entry, the details of the person |
| 2. Data Flow Planning and management | | | | who made the changes, the reasons for the |
| 3. Database planning and Creation | | | | changes, time and date |
| Planning a trial: The unit is responsible for the | | | | 4. Database must allow the entry of null values |
| quality of the data given to the statisticians and | | | | 5. In-built validation to assure the data in the |
| hence should be involved in all aspects of the trials | | | | database is accurate. |
| that will affect the collection of data. Like design | | | | Steps in data management: |
| of Case Report Forms, conduct of investigator | | | | 1. Data Entry |
| meetings, monitor and coordinator meetings and | | | | 2. Validation |
| regular interaction with the study staff at the site. | | | | 3. Correcting process |
| The flow of the data is generally determined by | | | | 4. Coding |
| the size of the trial and requires a good CRF | | | | 5. Locking the database |
| design and a monitoring plan. Smaller the trial all | | | | Conclusion |
| CRFs can be expected in a single delivery but if | | | | Data management is a series of steps which |
| the trial is big with ongoing recruitments CRFs will | | | | helps in entering the data produced from the trial |
| arrive in batches and not in a single batch and | | | | site, trapping the errors produced, validate and |
| hence it is important to establish how the data will | | | | corrects the data and provides it to the |
| be received before the trial starts. | | | | statistician. The main objective of the unit is to |
| The database is a system where in all the trial | | | | produce clean data which can be analysed by the |
| data will be entered in validation. | | | | statisticians. The data produced is the only basis |
| There are 2 formats in which the trial data can be | | | | for analysis of the trial and decide the result. |
| entered into the database. | | | | |