Page 300 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Internal Audits Research Administration SOP No: R106 SOP Title: Internal Audits
subject enrolled. For new studies, it is recommended that 100% of the newly acquired data be reviewed annually. Furthermore, it is encouraged that a full internal audit be completed upon inheriting an existing study from another coordinator and before the study is closed and prepared for long term storage. Subsequent internal audits for quality review may be done using a random selection process.
A random selection process should take into account the number of anticipated audits based on study design complexity, phase of development, investigator’s experience, previous site compliance, and rate of subject enrollment. Each study coordinator should discuss what the appropriate expectations for review should be in order to best support the study. For example, it is recommended that a phase II clinical trial with an OPAL score of “7” and eight subjects enrolled, carry out internal audits of five subjects once every three months. In order to select random subjects to audit, the following actions must be carried out.
• 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 Audit
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 Audit 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.
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