Pawdoo Paoprapat

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…[Read more]

Date of Birth should be replaced with “Year of Birth”.

Time of ICF signed should also be provided, with the instruction filling out in dd/mmm/yyyy format.

These variables should be indicated as well, with the answer in yes/no checkbox.
– 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

Having data standard enables authorities, clinicians, statisticians and data management team to the mutual understandings which can help the data planning, data collection, data tabulation and data analysis process.
It also support research study registration and tracking.

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 sys…[Read more]

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…[Read more]

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…[Read more]