Appendix_E3_-_SOP_Weekly_Reports.docx

FAERS-DMP STANDARD OPERATING PROCEDURE

FAERS WEEKLY STATISTICS REPORT

Table of Contents Applicability This Standard Operating Procedure (SOP) applies to the Program Manager (PM) for the FDA Adverse Events Reporting System-Data Management Program (FAERS-DMP) contract. The PM is responsible for generating and submitting a battery of metrics that quantify productivity under the contract. The PM e-mails the FAERS Weekly Statistics Report to the FDA CDER/OSE/RSS team on Mondays before 3:00 pm. This SOP addresses data elements and the process and procedures for generating the reports.

Reports/Queries

· FAERS Favorites/Case Queries

· Pipeline Report

· Pipeline Case Report (which screen shot is this, pls?)

· Pipeline Age Range Report

· Pending Report

· User Count Report

· eSub Case Metrics Report

· DCC Weekly Report

· Products of Concern Report Overview of Report Process FAERS-DMP personnel manage paper reports delivered to the Document Control Center (DCC), where personnel sort and batch reports in groups of 10. DCC staff label the batches with uniquely numbered bar codes before delivering them to the Data Entry (DE) Team Leader. The DE Team leader supervises report or case processing in FAERS. Beginning in DCC and until cases are forwarded to FDA Safety Evaluators (SEs), they are tracked, which allows the PM to obtain report totals during various phases of processing.

In addition to paper reports, electronic reports or E2Bs comprise approximately 2% of FAERS-DMP’s total case volume. E2Bs enter the FAERS pipeline in the Coding unit.

The FAERS Weekly Statistics Report consists of several reports, developed in Microsoft Excel. The reports, collectively, present snapshots of real-time case volumes, beginning with manual counting of paper reports and continuing with tracking case totals through the pipeline until FAERS (online) processing is completed. Totals are typically tallied by MedWatch report types, which are identified as Case Priority in FAERS.[footnoteRef:1] Case Priority categories are: [1: Query results that show different data sets are noted within the pertinent sections of this SOP.]

· Expedited (15-Day) reports

· Non-Expedited (Periodic) reports

· Direct reports

· Expedited (15-Day) E2Bs

· Non-Expedited (Periodic) E2Bs Procedures for Paper Reports To generate and report weekly data, follow the steps below.

Step 1: FAERS MedDRA LOGIN Log onto the local computer network to access the FDA Adverse Event Reporting System (FAERS) MedDRA Coding Menu.

Double-click the FAERS icon on the computer desktop. After the FAERS splash screen closes, log into FAERS using the assigned User ID and password.[footnoteRef:2] The Case Browse window opens with an expanded view of the Favorites folder on the left (Figure 1). [2: FAERS Help Desk: Phone—240-912-6238; E-mail—AERSHELPDESK@fda.hhs.gov.]

Figure 1 Expanded View of Favorites List (List of Report Queries)

Step 2: CASES IN THE PIPELINE

1. In the Case Browse screen, click on each highlighted case query—one at a time (Figure 1). A pop-up shows the total case count for that report type in that pipeline segment (Figure 2).

Figure 2 Pipeline Totals by Case Priority

2. Enter each number into the appropriate cell on the Pipeline report (Figure 3).

Figure 3 Pipeline Tallies by Case Priority

Step 3: PIPELINE AGE RANGE

1. From the FAERS Case Browse screen, single-click the Run/Monitor Report icon (Figure 4). 1

2. Double-click Pipeline Report (Figure 4). 2

3. Single-click Run Now. 3

Figure 4 FAERS Case Reports Screen

4. Single-click the Refresh icon to display Pipeline report status (Figure 5). 1

Figure 5 Pipeline Report Request Screen

5. Once the report row shows Status C (Completion), double-click the row to display the Pipeline Report (Figure 6). The report displays Age or Days Processing for each report type.

NOTE: Subtract 3 days from the Age displayed to compensate for the number of days between the FDA Received Date and the date of delivery to the FAERS-DMP office.

Figure 6 Counts by Case Priority (report type) and Age

6. Copy each Age into the appropriate cell of the Pipeline Age Range report (Figure 7).

Figure 7 Pipeline Age Range Report Step 4: PENDING STATUS PIPELINE AGE RANGE

1. The Data Entry supervisor manually counts the batches and calculates the totals by report type. These totals constitute a Pending Count.

2. [The PM] Keys the Pending Count totals for each report type into the Pending worksheet after the Monday morning count. (Figure 9).

Figure 8 Weekly Pending Report Step 5: FAERS-DMP PRODUCTION

1. From the FAERS Case Browse screen, single-click the Run/Monitor Report icon (Figure 9). 1

2. Double-click User Count Report. 2

3. Enter the weekly From and To dates (of the previous week). 3 Format: Monday’s From date; Friday’s To date; use Numeric-Alpha-Numeric format as shown

4. Single-click Run Now. 4

Figure 9 User Count Request Screen

5. Single-click the Refresh icon to display the User Count Report status (Figure 10).

Figure 10 User Count Report Screen

6. Once the report row shows Status C (Completion), double-click the row to display the User Count Repor report (Figure 11).

7. The User Count Report represents New Case reports. To calculate the data for this report:

· Add the daily total for each New Case report type—Direct, Expedited and Non-Expedited (Periodic) reports.

· Calculate weekly totals, also by report type and key the totals into the appropriate weekly pipeline report (Figure 12).

Figure 11 User Count Report

8. Repeat Step 7 for the following report types:

· DDE

· Coding

· Coding-SE

· Validation (Note: Remember, Coding to SE is represented as Validation in FAERS-DMP production and in production-related reports)

Figure 12 Weekly Pipeline Report for New Case DE to DDE

Step 6: CASES RECEIVED On Monday mornings, the DCC Supervisor e-mails the DCC Weekly Report to the PM. The report shows daily totals of paper cases by report type (Figure 13).

Figure 13 DCC Weekly Report for Daily Procedures for E2Bs (Expedited and Periodic) To generate the E2B Case Metrics report, perform the following steps:

1. From the FAERS Case Browse screen, single-click the Run/Monitor Report icon (Figure 14). 1

2. Double-click eSUB Case Metrics. 2

3. Enter the weekly From and To dates (of the previous week). 3 Format: Monday’s From date; Friday’s To date; use Numeric-Alpha-Numeric format as shown

4. Choose Weekly as the Value for each field listed below: 4

· Graph Type

· Display Time Frame

5. Single-click Run Now. 5

Figure 14 eSUB Case Metrics Request Screen

6. Single-click the Refresh icon to display the eSUB Case Metrics report status (Figure 15).

7. Once the report row shows Status C (Completion), double-click the row to display the E2B Case Metrics report (Figure 16).

Figure 15 eSUB Case Metrics Report Status

Figure 6 Weekly Pipeline Report for eSUBs in Coding

8. Copy the totals for both Expedited and Non-Expedited eSUBS into the appropriate cells on the Cases Received/DCC Weekly Report (Figure 17).

Figure 7 Cases Received/DCC Weekly Report

TRACKING/REPORTING PRODUCTS OF CONCERN

Each week, the FDA CDER/OSE/RSS team supervisor provides drug names for addition to a Products of Concern list (Figure 18). FAERS-DMP maintains the list and submits a cumulative, updated list as part of the FAERS Weekly Statistics Report.

Figure 8 Products of Concern Chart

Glossary Pending Count—a daily hand count of cases before they are delivered to New Case Pipeline—representation of the various processing steps a case status of DDE, Coding or Validation Coding—paper copy or E2B reports in the data entry quality control unit Logged—User Count Report that captures cases in New Case status, where bar code labels are generated and applied to report pages Validation— paper copy or E2B reports in Validation status, where MedDRA codes are assigned

SOP Task Checklist Use this checklist as a sample self-checking tool to make sure the process was understood and implemented. Managers can tailor this checklist to match their group’s own implementation of FAERS-DMP requirements.

Change History

FDA and FAERS-DMP Approvals

PLACEHOLDER

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