8 Replies Latest reply: May 11, 2010 1:26 PM by 772386 RSS

    Data Locking

    522028
      Could some one describe to me what is data locking, why is it important and how can a user lock data in oracle clinical. and what levels can the data be locked.

      thanks for nay response
        • 1. Re: Data Locking
          45942
          Hi,
          Data lock - simply put is revoking all privileges to enter/modify/delete data. Once a database (data) is locked no changes are allowed. A final data lock is the last step in a study database life cycle (well atleast almost the last step :)) Data can be locked by SIte (investigator), Patient, DCM (Panel in Clintrial). For example site '002' has completed all entry/validation and no further changes are needed so this site can be locked (must be a simple menu item in OC).
          A data lock is performed after all CRF data is entered and validated/cleaned and there are no outstanding DCFs (Data clarification Forms) (typically after all data collection/validation is complete and sites have closed).
          A database (study) can be soft locked (i.e, interim lock at some timepoint and unlocked later) or a Final lock (i.e., Biostatistician has everything to proceed with his/her programming).

          From OC manual - "Freezing is the process of preventing changes or additions to data at the study,investigator, and patient levels."
          "Locking is the process of preventing changes to individual RDCIs or RDCMs."

          See chapter 10 of OC - Conducting a study manual.

          Please note that my explanation is based on my general understanding of OC (and a pretty good understanding of CDMS).

          Hope I helped.
          • 2. Re: Data Locking
            522028
            Thank you it is very help full. but what chapter 10 you are talking about. and where can i get it from.
            • 3. Re: Data Locking
              45942
              Here is the link to OC documentation -

              http://www.oracle.com/technology/documentation/pharmaceutical.html
              • 4. Re: Data Locking
                522028
                Thank you very much for the link. I also found this link yesterday while l was searching OC website.
                • 5. HI I want to learn oracle clinical
                  533898
                  Hi,
                  I want to learn clinical data management.could you please help.
                  Thanks
                  madhav.
                  m_madireddy@yahoo.com
                  • 6. Re: HI I want to learn oracle clinical
                    522028
                    Hi
                    There is a institute called ICRI that offers PG diploma in Clinical Data Management. It is a part time course, classes are on weekends.
                    Institute has 3 locations Delhi, Mumbai and Bangalore.

                    Hope this would be of some help.
                    • 7. Re: HI I want to learn oracle clinical
                      522028
                      Hi,

                      There is an Institute called ICRI that offers a PG diploma in Clinical Data Management. It is a part time course and the classes are on weekend.
                      Institute has 3 location Delhi, Mumbai and Bangalore.

                      Hope this would be of some help.
                      • 8. Re: Data Locking
                        772386
                        dear sir/madam

                        Please can u send me any doc related to proceedures in oracle clinical or can u send me any examples of proceedures

                        for validation ..

                        regards

                        mithelesh