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Hi Andrew, it is cleaver way how you created the CRF. Only some minor comments here, Would be better;
– to distinguish inclusion and exclusion criteria out of eligibility criteria
– to run page number
– study name should be indicated on the top of CRF
– physical exam part (HEENT /Cardiovascular /Chest /Abdomen /Musculoskeletal /Neurological /Other body system) seem like open ended questions. it would be helpful to make a choice to select from
normal / abnormal (if abnormal, please specify) this way you can get rid of some open ended fields? -
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These variables should be indicated as well, with the answer in yes/no checkbox line by line.
– Receipt of any vaccine during the 4 weeks
preceding the trial
– Plan to receipt of any vaccine during the 3 weeks
following the trial
– Vaccination against influenza in the past 6 months
– Self‐reported history of influenza infection in the
past 6 months -
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I have experience working in Veeva Vault system for eTMF for clinical trails which implemented those processes. Veeva Vault is used to store and manage data.
• Audit trial: there is audit trails to check who uploads/modifies/access/view and when those activities were performed on the documents.
• Authentication : in order to access the system, the staff must 1) have company’s email then 2) enter the authentication code received from the system.
• Edit check and logical check : the system also shows edit checks and logical check, i.e. there are the 1) reveived date and 2) document date. The received date of the filed document must not be before the document date itself. If fails to follow this concept, the auto pop-up message will show and prevent me from entering the illogical date.
Data backup and recovery plan : these are present on the system, the essential trial documents in the already closed-out studies are archived for 15 more years. -
I had assisted CRA performing eTMF documents uploading and archiving during the on-going until the study close out. To do this process well, one should have basic knowledge of the trial, be logical and attention to details to be able to re-check the completion, accuracy and timeliness the documents filed in eTMF. Also, making sure that the identifiable information of the subjects must not be showed on the documents processed to eTMF.
Steps I should have improved to my project: the clear communication among the team should have been put in place to emphasize on the timeliness of the documents collection so that the document filing in eTMF could be performed routinely and on a timely manner and to prevent overwhelming the tasks towards to study closure. -
I have experience, indirectly, in handling/sorting secondary data collection/processing of safety reports on the Susar Line Listing for some certain drug compounds, submitted to EC.
1. Purpose of data collection : safety reports are collected from SAEs occurred during the trials are grouped and summarized as Susar Line Listing to be reported to the authorities (i.e. EC, TFDA)
2. It was secondary data collection
3. Methods used for data collection : Safety reports are collected from SAEs occurred during the trials from the participating sites globally. The safety reports then are then gathered and converted into Susar Line Listing which is submitted to local EC. However, the prior to the EC submission the safety reports on the line listing must be categorized and summarized to the 10 of the most frequent adverse event cases.
4. Any problems occurred : because of lacking of technical knowledge, it takes time to sort out and categorized the cases to specific events.
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