Page 202 - eBook Version 8 Book 1 of 2 JUL 2022

Internal Quality reviews Research Administration SOP No: R-Reg-104 SOP Title: Internal Quality Reviews
• Select 5 random subjects numbers using the link http://www.randomizer.org/form.htm as follows:
• For the question ‘How many sets of numbers do you want to generate?’ enter ‘1’.
• For the question ‘How many numbers per set?’ enter ‘5’.
• For the number range enter ‘From: 1 To: (enter the last subject number
entered in the clinical trial)’.
• For the question ‘Do you wish each number in a set to remain unique?’ answer ‘Yes’.
• For the question ‘Do you wish to sort the numbers that are generated?’ answer ‘Yes: Least to Greatest’.
• For the question ‘How do you wish to view your random numbers?’ enter ‘Place Markers Off’.
• Select ‘Randomize Now!’ at the bottom of the screen.
• Print off the numbers selected which will appear on a new screen.
5.3 Conduct the Internal Quality Review
5.3.1 Obtain direct access to the eResearch systems, the electronic data capture (EDC), subject binders, subject’s medical records, and regulatory binders.
5.3.2 Confirm the study approvals as indicated in section 5.1.
5.3.3 Use the Internal Quality review Tool referenced in this SOP to complete review of:
5.3.3.1 Subject Information and enrollment progress.
5.3.3.2 Study Status and regulatory maintenance.
5.3.3.3 Study Data: Verify data is accurate legible, verifiable and consistent across the subject’s binder, subject’s medical records, results, EDC entry, and documentation.
5.3.3.4 The quality reviewer will generate report upon completion of the quality review and notify members of the team if further action items need to be addressed.
5.4 Addressing Quality Review Observations
Upon completing the internal quality review report with the team, evaluate the observations and devise a plan for addressing the items and documenting the corrective actions.
5.4.1 Delegate the items for corrective action to the appropriate study team member.
5.4.2 Discuss how each item should be corrected.
5.4.3 Discuss a time course for resolving each item.
Page 5 of 7