Each MESA Field Center clinic will be site-visited in September or October. The site visit team will consist of four to five people: a PI, a Study Coordinator, and representatives from the NHLBI and the CC, as shown on the table below.
Each site visit will last 1-ẵ days. Two different schedules will be used: a full day followed by a morning, or an afternoon followed by a full day. Below are examples of schedules. These can be adjusted according to the usual schedule at your individual clinic, and will also be affected by the timing of the site team’s arrival and departure flights. Some site visits are scheduled “back-to-back,” so the schedule choice is pre- determined. At other sites either schedule looks like it would work, so the site can work with the team to determine the best schedule.
Full-day + morning schedule First day:
8 am “Meet & Greet” with staff Explain purpose of visit 8:30 Observe clinic visit
PI meet with PI (sometime during the day) 4-6 pm Look at set-up of clinic, files, data management
Look at set up for completing and tracking QC Second day:
8 am Finish any remaining tasks Prepare summary of visit Give verbal report to staff 2 or 3 pm Site team travel to next site Afternoon + full day schedule
First day:
3 pm “Meet & Greet” with staff Explain purpose of visit
Look at set-up of clinic, files, data management Look at set-up for completing and tracking QC Second day:
8 am Observe clinic visit
PI meet with PI (sometime during the day) Prepare summary of visit
4 pm Give verbal report to staff
2. DATA MANAGEMENT
2.1. QA Activities
FC Staff Qualifications
No specific qualifications are required.
FC Staff Training
Ms. Bonnie Lind and Ms. Norma Dermond conducted central training for data management in Chicago in April of 2000, prior to the beginning of the baseline examination. FCs were required to identify a primary data manager and back-up data management assistant. At least one of these designated individuals was required to attend this training session. If a data manager and assistant were not yet identified at a
particular FC, at least one other MESA staff member (preferably the FC study coordinator) was required to attend the training. Training included a detailed demonstration of entering (scanning), verifying,
transmitting, and tracking all data forms including recruitment forms, baseline examination clinic procedure forms, and medication data forms. In addition, computer stations and scanners were set up so that managers could familiarize themselves with and practice the required data processing steps for the entire baseline examination sequence starting with initial recruitment and ending with the exit interview.
After subsequent upgrades to the MESA data management software, a second central training session was held for data managers at the CC in July of 2000. All data managers were designated at this time and were required to attend the central training. Study coordinators were also encouraged to attend. Training covered all the steps involved in data processing and management and emphasized those steps affected by the upgrades to the software system.
FC Staff Certification
To become certified as a data manager for MESA, the manager trainee must
read Section 6 in the MOP.
attend the central training session in Seattle (or receive local training provided by a certified FC data manager as described below)
successfully enter, verify (when necessary), transmit (to the CC), and track an entire set of baseline examination forms
A back-up data manager and/or new data managers hired due to staff turnover should be trained and certified locally by the certified primary data manager. Back-up and new data managers must demonstrate the ability to perform all the skills required by the data manager and covered at central training.
Specifically, the certified data manager trainee must be observed performing and successfully completing the skills enumerated on the MESA Data Management Certification Checklist by the primary data manager.
Completed checklists should be sent to the CC Maintaining Certification
To maintain certification, the data manager and back-up data manager must
enter, verify, transmit, and track, at minimum, an entire week’s worth of data every two months.
repeat the original certification process before each new exam cycle.
Reader Training and Certification Not applicable.
2.2. QC Activities
FC QC Activities
Periodically, at the request of the CC, FC data managers will be required to fax copies of completed forms (to be specified by the CC) so that data accuracy can be assessed. Data on the forms sent to the FCs will be compared against the existing data in the CC database (generated at the time the forms were scanned). Any differences will be identified and reconciled jointly by the FC and CC.
RC QC Activities Not applicable.
CC QC Activities
QC Data Monitoring and Statistical Analyses
The CC tracks and monitors the completeness of all data transmissions from FCs to the CC, from FCs to RCs and from RCs to the CC. A description of these activities is in Chapter 6 of the Manual of Operations (MOP). The CC also performs data checks for outlying data values that may represent potential errors in the data.
QC Reporting
Quarterly reports on outlying data values will be sent to the FCs and for review and reported to the SC.
2.3. Supporting Documentation
MESA Data Management Certification Checklist
MESA Data Management Certification Checklist
DATE: Field Center:
mo day year
Manager Trainee Name/ID:
Data Manager Name/ID:
Purpose of Evaluation:
Certification Site Visit
Please check the appropriate box if manager performance is satisfactory for each line item. Please note any comments or remedial action taken in ‘Comments’ section if performance was not satisfactory.
Preparation:
1. Accesses the MESA web site and posted reports; prints specified report and faxes to CC.
2. Pulls a sample of households as required.
3. Enters results of contact attempts into sampling frame database.
4. Enters recruitment status into recruitment database.
5. Creates a daily calendar.
6. Runs reports from sampling frame, recruitment, and clinic databases; faxes to CC.
7. Prints a complete set of recruitment forms and exam forms.
8. Prints specific forms for selected ID numbers.
9. Scans and verifies a complete set of clinic exam forms.
10. Scans and verifies a complete set of recruitment forms.
11. Enters participant contact information using the on-line form.
12. Enters medications data using the medications data-entry program.
13. Updates data in the database.
14. Performs daily transmissions to Reading Centers.
15. Performs weekly transmission to CC.
16. Installs software updates sent by CC.
Comments:
Corrective Action Taken:
Supervisor / Site Visitor Signature