The National Institutes of Health’s Post

Step up your game after implementing #ValidationManager. Explore 4 key tips that help your laboratory advance towards more efficient verifications 📈👇 → https://lnkd.in/epE_FxSM . . . #Clinicalbiochemistry #ClinicalDiagnostics #ClinicalChemistry #Microbiology #Microbiologia #Virology #Hematology #Laboratory #Laboratories #Laboratorio #ClinicalLaboratory #ClinicalLab #IVD #PublicHealth #Immunology #Diagnostics #InfectiousDiseases #BiomedicalScience #LabAutomation #Finbiosoft

⚡30x query latency improvement ⚡48x batch data refresh ops improvement Instead of being forced to wait up to 20 minutes for query results, scientists at UCB now have access to real-time data and query results in 20 seconds, reducing query latency by more than 30X. They can check on available data sets in real time, eliminating delays between data publication and availability in the data mart. The platform’s batch data refresh operation run times dropped by 48X, from 4 hours to 5 minutes. Click the link below to learn more!

From the simple Remote Data Entry (RDE) systems to the advanced systems of today, #EDC has evolved a long way. So, what are the advantages and challenges that are associated with #electronicdatacapture systems? And what are the features should you look for while choosing an EDC system? Read our full blog to learn in detail. Check out our very own advanced EDC platform: https://bit.ly/3V2lwHb #ClinicalTrials #Blogs #ClinicalResearch #LifeSciences 

Check out my new Blog on overview of Clinical trial and Clinical Data Management. #clinicaltrials #clinicaldatamanagement #CDM . Hope this helps the beginners.

Demystifying  Final Database Lock (DBL) Checklist for Clinical Data Managers!!! . . . . The 'Final Database Lock (DBL) Checklist' is our roadmap to accuracy and successful DBL. It gives the step by step process to reach clean database lock. What goes inside ‘Final Database Lock Checklist?’ Lets Explore!!! Below are the major componenets of DBL Checklist!! ⭐𝗗𝗮𝘁𝗮 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗤𝘂𝗲𝗿𝘆 𝗥𝗲𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻    - All data queries have been resolved.    - Data discrepancies identified during cleaning have been addressed.    - Clean Patient tracker is updated with all data clean status. ⭐ 𝗗𝗮𝘁𝗮 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗵𝗲𝗰𝗸𝘀 - Comprehensive data quality checks, including range checks, consistency checks, and outlier identification, have been conducted.    - Validation checks have been executed to ensure accurate data entry, adherence to protocol, and compliance with CRF completion guidelines. ⭐ 𝗗𝗮𝘁𝗮 𝗟𝗶𝘀𝘁𝗶𝗻𝗴𝘀 𝗥𝗲𝘃𝗶𝗲𝘄    - Detailed data listings, including subject profiles, data summaries, and key variables, have been generated, scrutinized, and approved. ⭐ 𝗗𝗮𝘁𝗮 𝗥𝗲𝗰𝗼𝗻𝗰𝗶𝗹𝗶𝗮𝘁𝗶𝗼𝗻    - All discrepancies between source documents (e.g., CRFs, source data,) and the database have been meticulously addressed and resolved. ⭐ 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗖𝗼𝗺𝗽𝗶𝗹𝗮𝘁𝗶𝗼𝗻    - Data cleaning reports, including listing of resolved queries and data discrepancies, are complete and well-organized.    - Query tracking log and query resolution documentation are attached. ⭐ 𝗦𝗮𝗳𝗲𝘁𝘆 𝗥𝗲𝗰𝗼𝗻𝗰𝗶𝗹𝗶𝗮𝘁𝗶𝗼𝗻    - Safety data has been reconciled between the clinical database and safety database, ensuring accuracy and consistency. ⭐ 𝗖𝗼𝗱𝗶𝗻𝗴 𝗖𝗼𝗻𝘀𝗶𝘀𝘁𝗲𝗻𝗰𝘆     - Medical coding (MedDRA, WHODrug) has been applied consistently across the study data and discrepancies have been resolved. ⭐ 𝗔𝘂𝗱𝗶𝘁 𝗧𝗿𝗮𝗶𝗹 𝗥𝗲𝘃𝗶𝗲𝘄    - The audit trail has been reviewed for accuracy and completeness. ⭐ 𝗠𝗲𝘁𝗮𝗱𝗮𝘁𝗮 𝗩𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻    - Metadata, such as CRF versions, database version, and protocol details, are consistent and have been validated against source documents. ⭐ 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲 𝗟𝗼𝗰𝗸 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻     - A comprehensive database lock memorandum/report has been compiled, including details of actions taken and validation performed. ⭐ 𝗣𝗼𝘀𝘁-𝗟𝗼𝗰𝗸 𝗔𝗰𝘁𝗶𝘃𝗶𝘁𝗶𝗲𝘀     - A post-lock plan for data transfer, statistical analysis, archiving  and further reporting has been documented and shared with relevant teams. ⭐ 𝗦𝗶𝗴𝗻-𝗼𝗳𝗳 𝗮𝗻𝗱 𝗔𝗽𝗽𝗿𝗼𝘃𝗮𝗹     - Necessary approvals have been obtained from designated individuals, indicating their confirmation of the accuracy and completeness of the database lock process. What other components do you include in the checklist? Let me know in comments #clinicaldatamanagement #clinicalresearch #clinicaltrials

Clinical Data Management-----Steps👇 Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from trials by keeping the number of error as low as possible.This helps to produce a drastic reduction in time from drug development to marketing. The CDM activities in a Trial includes: Database Design - Databases are software applications that are built where the trial related informations like the sites, investigators, patient visits & data are represented and the CRFs are designed for patient information collection.Before implementing such databases there is "System Validation" performed to check the data security, system requirements, user requirements & regulatory compliance. Data Collection - Data collection are done on CRFs that may exist in paper form or electronic forms.In case of e-CRF based study the investigator will log in to the CDM system and enter data at the site. CRF Tracking - The data entered in the CRF is monitored by the Clinical Research Associate (CRA) for completeness and filled CRFs that are handed over to the CDM team is tracked by team for any missing or illegible data.In case of lost data clarification is obtained from the Investigator. Data Entry - Data entry is done according to the Data Management Plan (DMP).Usually a double data entry is done by two operators separately(applicable for paper CRF studies) the second pass entry helps in identifying any transcription . Data Validation - Data Validation validates the data according to the protocol. Edit checks are written to identify discrepancy in the data entered into the database. In case of discrepancy, it will be highlighted in the database and DCFs are sent to the site. Discrepancy Management - It is also known as Query Resolution. This includes reviewing discrepancy, identifying the cause & resolving or else declare as irresolvable. Based on the type, data discrepancy can be either flagged to the investigator for resolving or closed in house by Self Evident Correction (SEC) without sending DCFs to the site. Medical Coding - This helps in classifying medical terms in the trial to the standard dictionary terms. Usually Medical Dictionary for Regulatory Activities(MedDRA)are used to code for adverse events, other illness & WHO Drug DictionaryEnhanced(WHO-DDE)is used for coding medications. Database Locking - After valuable quality check and assurance final data validation is run & if there is no discrepancy, the SAS database is finalized. All the clinical data management activities to be completed before database locking.The final clean data is extracted for analysis. Usually no changes in the database can be performed after locking but in case of critical issues database updation can be performed but it needs proper documentation and audit trail needs to maintain sufficient justification of updating locked database. #CDM

Clinical Data Management-----Steps👇 Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from trials by keeping the number of error as low as possible.This helps to produce a drastic reduction in time from drug development to marketing. The CDM activities in a Trial includes: Database Design - Databases are software applications that are built where the trial related informations like the sites, investigators, patient visits & data are represented and the CRFs are designed for patient information collection.Before implementing such databases there is "System Validation" performed to check the data security, system requirements, user requirements & regulatory compliance. Data Collection - Data collection are done on CRFs that may exist in paper form or electronic forms.In case of e-CRF based study the investigator will log in to the CDM system and enter data at the site. CRF Tracking - The data entered in the CRF is monitored by the Clinical Research Associate (CRA) for completeness and filled CRFs that are handed over to the CDM team is tracked by team for any missing or illegible data.In case of lost data clarification is obtained from the Investigator. Data Entry - Data entry is done according to the Data Management Plan (DMP).Usually a double data entry is done by two operators separately(applicable for paper CRF studies) the second pass entry helps in identifying any transcription . Data Validation - Data Validation validates the data according to the protocol. Edit checks are written to identify discrepancy in the data entered into the database. In case of discrepancy, it will be highlighted in the database and DCFs are sent to the site. Discrepancy Management - It is also known as Query Resolution. This includes reviewing discrepancy, identifying the cause & resolving or else declare as irresolvable. Based on the type, data discrepancy can be either flagged to the investigator for resolving or closed in house by Self Evident Correction (SEC) without sending DCFs to the site. Medical Coding - This helps in classifying medical terms in the trial to the standard dictionary terms. Usually Medical Dictionary for Regulatory Activities(MedDRA)are used to code for adverse events, other illness & WHO Drug DictionaryEnhanced(WHO-DDE)is used for coding medications. Database Locking - After valuable quality check and assurance final data validation is run & if there is no discrepancy, the SAS database is finalized. All the clinical data management activities to be completed before database locking.The final clean data is extracted for analysis. Usually no changes in the database can be performed after locking but in case of critical issues database updation can be performed but it needs proper documentation and audit trail needs to maintain sufficient justification of updating locked database. #CDM

Exploring Clinical Data Management Opportunities and Growth #clinicalresearch #clinicaldatamanagement #healthcarejobs #clinicalresearch #clinicaldatamanagement #healthcareupdates #healthcarecareers #bsc #msc #bds #biotechnology #lifesciencestudent #careerguidance #cliniminds #clinimindsplacements #skilldevelopment

Urgent Requirement Software Engineer Need a candidate who can do below Must Have designing experience Testing experience Coding experience Modifying experience and debugs computer software Under broad supervision, designs, codes, tests, modifies and debugs computer software. Job Summary: Rebuild existing TB Patient Management (TBPM) System in a modern architecture/framework. Update TB workflows to better align with TBPM processes. Eliminate the many steps involved updating various data input screens Build in processes to ingest TB eCRs and ELR data feeds Redevelop the Report of a Verified Case of TB (RVCT) process. Streamline the data extract Message Mapping Guide (MMG) for transmission to the CDC. The TBPM system is to replace the existing TBPM system built some 15 years ago, as workflows and processes have changed within the TB section, the tool used to track patients with TB hasn't kept up to date due to there not being a designated resource to keep up with these changing protocols. This has led to a system that no longer supports the day to day activities needed to be accomplished managing TB patients within Georgia. The current system has multiple tabs that split up the data entry into groups of information corresponding to the tabs heading. It is envisaged this way of organizing the various data grouping will stay the same in the rebuilt version. Current tab organization Epi Investigation - Additional Epi investigative information, genotyping, linking with a known case etc. Documents - supporting documentation upload area Imaging - Chest imaging results including type of image taken CT scan, MRI etc. Tests - Blood tests and results information with an upload function for the actual test report image. Diagnosis - Case verification status, Suspect, Not a case etc. CI - Contact Investigation Summary RVCT - This report gets built over time and once complete gets sent to the CDC. Patient - Patient Demographics, Address History etc. Assessment - Site of TB, previous diagnosis of TB and Risk factors Meds - TB Medications being taken DOT - Directly Observed Therapy and if treatment/meds stopped the reason why Susceptibility - Molecular Susceptibility Bacteriology - Drug susceptibility etc. MDR - Observes the side effects of the various prescribed medications Thanks & Regards Hari Krishna Ph +1928-554-7991 Email:harikrishna@smartitpros.com Smartitpros.com