Week 4

Question 1

PSSV

Answer 1

Pre Study Selection Visit

Question 2

PTA

Answer 2

Pre-Trial Assessment

Question 3

PSV

Answer 3

Pre Selection Visit

Question 4

SSV

Answer 4

Site Selection Visit

Question 5

SV

Answer 5

Selection Visit

Question 6

What is a Pre-Site Selection Visit?

Answer 6

A monitoring visit looking to determine the following question:

• Does this site quality to conduct the study they bid for according to the requirements of the study protocol?
  
  • The site has not been awarded the study as of yet

Question 7

Standard Operating Procedure

Answer 7

SOP
The ICH-GCP defines the SOP as “detailed written instructions to achieve uniformity of the performance of a specific function”

Question 8

Objectives of a Pre-study visit are to:

Answer 8

• Asses the adequacy of the site’s facility
• Present most current Protocol slides to the PI and RC
• Review the site’s access to the right patient population and assess the site’s interest in the study

Question 9

Tips for PSV?

Answer 9

• Gather IRB information
• Be familiar with the protocol training slides
• Make sure you have a response to all questions on your trip report

Question 10

PSV and SIV tasks

Answer 10

• Assess the adequacy of the facility by doing a site tour with RC (PSV & SIV)
• Present Protocol slide presentation (PSV & SIV)
• Review the site’s access to the right patient population & review recruiting goals according to the Protocol (PSV & SIV)
• Review the site’s Regulatory Binder to make sure the site is up to date with all Essential Documents (SIV)
• IP Accountability (SIV)

Question 11

What is an SIV?

Answer 11

An SIV is a monitoring visit looking to determine the following question:

• Is the site ready to begin enrolling subjects?
• The site has now been awarded the study

Question 12

During the PSV/SIV

Answer 12

1. Sign the site visit log
2. Perform protocol Training
3. Perform Site tour
4. Review and complete regulatory (SIV only)
5. Perform IP Accountability