# Presentation: 602015

## What to Expect with the On-Site Interviews

## The moment you have turned in your document submission, begin to prepare for the site visit!

**"Pearls"**

## “To Do List” Before Visit

- Establish Rapport with your NCQA Contact - they are reviewing your documents during this period
- Contact them and be sure they received your package and all is going well with your document review
- Work with NCQA to establish a schedule for their visit (how many days, who they want to see, etc.)

## To Do List (Cont.d)

- NCQA will send surveyor info. If you have conflict of interest, you must notify NCQA in writing within 5 days
- 4 week prior to site visit you should get feedback on your documentation submission. You will get DTC with evaluation to date. You have 7 days to submit additional documentation

## All OFFICIAL correspondence between NCQA and your station goes directly to Director – be sure they let you know immediately!!!!

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## Be sure your key players are going to be available – negotiate the schedule!

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## Review Protocol Files

- Files need to be orderly and professional in appearance
- Materials need to be filed in consistent manner
- Develop a guide to finding materials in files

## Possible ways to help reviewers

- Know your forms and be able to find where you can support each standard that will be reviewed on site
- Look at questions you ask on your application and map to standard ( e.g. (CRB5B1 is addressed by PI on IRB Form 1 page 5 question 8)

## Use the Protocol Listing Worksheet

- Use the Data Collection Tools
- Find any missing items from your files: reviewer worksheets, cover memos requesting waiver of consent, etc.
- Enlist help – QA staff, IRB members, R&D members, Research AO, etc.

## Prepare those who will be interviewed

- Schedules – be sure they will be available
- Set aside individual coaching time – the more time you spend going over procedures with them the more comfortable they will be and the entire visit will be less stressful

## Leadership Briefing

- Schedule a meeting with everyone who will be involved in the NCQA process (Director, COS, Chair R&D, Pharmacy Reps. Chair(s) IRB,
- Modify sample briefing slides to fit your facility
- Assure everyone is on the same page

## Prepare those who will be interviewed (cont’d)

- Check with Director as to who should be in opening and closing conference
- Purpose of interviews are to “explain, clarify and confirm” documented evidence submitted

## Go down to the Pharmacy yourself 

**"Pearls"**

- Go down to the Pharmacy yourself
-  ... Now!

## Does file have a copy of the approved protocol and VA Form 10-9012
Are copies of signed consents there for all subjects who have received drug
Is there a investigational drug log covering all items in standard
Has log been completed properly

- Does file have a copy of the approved protocol and VA Form 10-9012
- Are copies of signed consents there for all subjects who have received drug
- Is there a investigational drug log covering all items in standard
- Has log been completed properly

- Audit Pharmacy Records for Active and Closed Study Records

## Last Minute Details

- Be sure NCQA reviewers have directions, transportation and hotel
- NCQA promises to provide you with a list of protocols to pull – be sure you get this
- Develop a guide for your records to make it easy to find information

## Housekeeping Arrangements

- Have a secure, comfortable workspace near your file area
- Arrange for coffee and water
- Get menus from local take out restaurants
- Arrange for private rooms for the one-on-one interviews.  You will need either one or two rooms depending on how many reviewers will be assigned.

## Housekeeping Arrangements (cont’d)

- Arrange for parking
- Give them a copy of the final schedule
- Tidy up IRB offices (be sure everything is locked appropriately)

## NCQA Site Visit And Beyond

- Take a deep breath it is Opening Conference time:
-  NCQA team, Director, Chief of   	Staff, ACOS/R&D, HRPP 		Coordinator, Chair R&D, RCO
- NCQA has scripted agenda

## Preparations for Opening Conference

- Arrange for Director’s Conference Room
- Focus is on Institutional Official and s/he should take the lead in answering questions
- Takes about one hour

## Preparations for Opening Conference   (cont’d)

-  Be sure Director knows scope of projects, has understanding of the ethical principles of human subject research, can address how institution supports the HRPP, provides oversight to IRB, manages conflict of interest, manages investigational products, assures appropriate training and embraces QI

## Tours

- A NCQA reviewer will review at least 3 *active* studies in the Pharmacy
- Go with the NCQA reviewer and have your Research Pharmacist or Chief of Pharmacy present!

## Pharmacy Tour

- Pharmacy tour/audit, if you are prepared will probably only take one hour
- Be sure everything is tidy and secured
- May ask questions about how they are working with investigators, how drugs are received and recorded, how they get IRB approval notices

## Tour Continued

- A reviewer will also tour the IRB area to see if there appears to be adequate space and security
- A reviewer may also ask to see your computerized tracking system to see that confidential information is appropriately safeguarded

## Interviews

- Primary purpose of one-on-one interviews
- Explain
- Clarify
- Confirm
- It is truly one-on-one

##  One-on-One Interviews

- VAMC HRPP Official
- VA R&D Committee Chairperson
- IRB Coordinator/Administrator
- IRB Chairperson
- IRB Members (2)

## IRB Coordinator Interview Topics

- Time depends upon issues picked up in document review. Topics include:
- Protocol and application review process
- IRB meeting materials
- Tracking of documents and materials
- Responsibilities of office staff
- Continuing and expedited review process

## IRB Coord. Interview Topics (cont.)

- Process for dealing with questions and complaints
- Protocol file management and organization
- Does IRB Coordinator feel s/he is getting support to do the job- is budget adequate
- Resolve questions resulting from document review

## R&D Chair or Possibly ACOS/R&D Interview Topics

- Oversight provided HRPP
- Relationship between IRB and R&D
- Resolution of any issues between both committees

## IRB Chair Interview Topics  (one-on-one interview)

- Conduct of/discussion at meetings
- Roles and responsibilities of IRB support staff
- Role of IRB Chair
- How local IRB determined certain issues such as appropriate patient compensation, content of flyers, etc.

## IRB Chair Interview Topics (Cont.)

- Use of expedited review
- Use of ad hoc reviewers
- What materials are provided to members
- Informed consent/waiver of informed consent issues

## Select an experienced, articulate IRB member (and a back up)!

**"Pearls"**

## IRB Member Interview Topics (one-on-one interview)

- Does IRB use primary and secondary reviewer system?
- What materials does s/he get for a meeting?
- Does s/he get materials in enough time?
- Does s/he feel there is adequate time for discussion – is his/her voice heard?
- What kind of training has s/he had?

## File Review

- The majority of the time they will spend reviewing your files
- Provide them with a guide
- Be available to pull files, find materials in the files and answer questions – if they can’t find something you can look for documentation in minutes, corres. etc.

## Be prepared to 

**"Pearls"**

- Be prepared to
- come in early and stay late

## Be sure you meet with the team leader and discuss their findings before the exit conference. Any disputes over file review must be resolved before they leave!!!

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## Exit Conference

- Include all who attended opening conference
- Survey team will summarize findings
- Survey team does not make decisions about institution’s accreditation

## Good Luck

- from all of us
- associated with ACE!