Adverse Event and Medications Coding



PURPOSE/SCOPE

1.1 This work practice guideline is used in Biometry to provide a basis for performing adverse event and concomitant medication coding. This will provide a method for the bioanalysts to perform coding decisions and create mapped datasets with coded values used in analysis and reporting.

1.2 The process will define the methods for coding with the MedDRA and Costart dictionaries for Bioanalysts internal to Biometry. It is not intended to be applied to external CROs or used with other thesaurus dictionaries.

RESPONSIBILITY

2.1 A team member within data management is responsible for ensuring the source data is available.

2.2 A Bioanalyst assigned to the specific study is responsible for refreshing the source data and then performing the coding and reporting of the coded terms.

2.3 A Medical Monitor or designee is responsible to review mapping and/or classifications such as ATC classifications.

DEFINITIONS aND TERMINOLOGY

3.1 Software – This can apply both to larger systems like the SAS System or SAS macros or single use SAS programs.

3.2 Coding – In the context of adverse and concomitant medication coding, this is the process of matching the verbatim term to the specified preferred term.

3.3 Mapping – In the context of adverse and concomitant medication coding, this is the process of creating a new data set with the preferred terms.

REFERENCES AND RELATED SOPs

4.1 SAS Programming Life Cycle

4.2 Risk Assessment

4.3 Data Flow

4.4 SAS User Authorization

PROCEDURE

5.1 Accessing Sy/Map

5.1.1 The Sy/Map system can be accessed by a Bioanalyst, Medical Reviewer, Statisticians or any other member in Biometry who has interest in adverse event and drug coding.

5.1.2 Using internet explorer, go to the intranet website: .

5.1.3 User manuals and installation instructions are available through this intranet website.

5.1.4 Using internet explorer, go to the intranet. Click on the Sy/Map hyperlink to get started.

5.1.5 Enter your user name and password to enter the system. If you do not have a user name and password, contact the coding administrator or the Manager of Biometry to create one for you.

5.1.6 Click on the “Study Conduct” tab. Select the current study through the pull down menu. If you do not see your study on the list, do the following.

5.1.6.1 From the “Administration Tools” screen, click on the “User Privileges” icon form the main administration screen.

5.1.6.2 Pull down the menu “Current Object” and select the study that you wish to have access to.

5.1.6.3 Click on the “View” button next to the current object.

5.1.6.4 Identify the owners of the study and contact them to request for permissions.

5.2 Performing Auto coding

5.2.1 A Bioanalyst would perform an auto code usually when there is new source data (i.e. from Data Fax) created or updated. This process will reveal any terms that have not been mapped and prompt for manual coding.

5.2.2 As a prerequisite, verify that you have the following:

5.2.2.1 A valid Sy/Map account with access to the specified study.

5.2.2.2 A mapping session has been configured for the particular study.

5.2.3 Log onto the Sy/Map tool and navigate to the mapping session by doing the following:

5.2.3.1 Click on the “Study Conduct” tab from the main administration screen.

5.2.3.2 Select your current study thorough the “Current Study” selection list.

5.2.3.3 Click on the “Thesaurus” icon.

5.2.3.4 Identify which dictionary type you wish to use including: Costart, WHO Drug and MedDRA. Click on the correct choice.

5.2.4 Click on the “Auto Code” button to perform the auto code. If you have not setup a mapping session, click on the “New” button and follow the instructions of the wizard.

5.2.5 Review the results of the auto code request which is delivered to you via email upon completion.

5.2.6 The Bioanalyst can use this report in the next phase of manual coding. In addition, the Bioanalyst can forward this report to the Medical Reviewer, Statistician or fellow Bioanalyst working on this project as a status update.

5.3 Performing Manual Coding

5.3.1 The Bioanalyst performs a manual coding after an auto code is executed. This ensures that the latest unmapped terms are listed.

5.3.2 As a prerequisite, verify that you have the following:

5.3.2.1 A valid Sy/Map account with access to the specified study.

5.3.2.2 A mapping session has been configured for the particular study.

5.3.2.3 Auto code has been applied for the particular study and mapping session.

5.3.3 Log onto the Sy/Map tool and navigate to the mapping session by doing the following:

5.3.3.1 Click on the “Study Conduct” tab from the main administration screen.

5.3.3.2 Select your current study thorough the “Current Study” selection list.

5.3.3.3 Click on the “Thesaurus” icon.

5.3.3.4 Identify which dictionary type you wish to use including: Costart, WHO Drug and MedDRA. Click on the correct choice.

5.3.4 Click on the “Manual Code” button to perform the Manual Coding.

5.3.5 Select the unmapped terms from the list and click on the “Start Map” button.

5.3.6 Select the recommendations or search for the preferred term. Depending on the dictionary type, there may be other choices to select for the mapping selection.

5.3.7 If you are sure on the mapping decision, select the “final” choice and click on the “Map” button.

5.3.8 For terms that you would like to make a guess which require review, select the “tentative” choice and click the “Map” button.

5.4 Medical Review

5.4.1 All tentative terms are sent to a Medical Reviewer or a Senior Bioanalyst to review. The Reviewer logs onto the system and either confirm or reject the mapping decision. This is accomplished through the “Review” button from the mapping session screen.

5.4.2 For adverse event coding, the reviewer needs to clarify if the mapping contains the proper SOC corresponding to the verbatim term. For medical drug mapping, the reviewer needs to review the indication and route to verify that the selected ATC code is correct.

5.4.3 For rejected terms, the reviewer can apply searches and recommend the proper mapping and communicate this to the original Bioanalyst. The Bioanalyst can apply the coding as a learning experience.

5.5 Creating Coded Dataset

5.5.1 A Bioanalyst can create a newly mapped dataset on a periodic basis based on updated source data. It can therefore be done upon request or at any point.

5.5.2 As a prerequisite, verify that you have the following:

5.5.2.1 A valid Sy/Map account with access to the specified study.

5.5.2.2 A mapping session has been configured for the particular study.

5.5.2.3 Auto code has been applied for the particular study and mapping session.

5.5.2.4 Although not required, it is recommended that manual coding has been applied to map all the unmatched terms that were not captured during auto code.

5.5.3 Log onto the Sy/Map tool and navigate to the mapping session by doing the following:

5.5.3.1 Click on the “Study Conduct” tab from the main administration screen.

5.5.3.2 Select your current study thorough the “Current Study” selection list.

5.5.3.3 Click on the “Thesaurus” icon.

5.5.3.4 Identify which dictionary type you wish to use including: Costart, WHO Drug and MedDRA. Click on the correct choice.

5.5.4 Click on the “Map” button to initiate the creation of the coded dataset.

5.5.5 Review the mapping request noting the name of the new destination dataset that is going to be created.

5.5.6 Upon completion of the request, review the newly created dataset to see if the preferred terms and related fields are populated. This can be accomplished through the SAS viewer or the data viewer tool which is part of the Sy/Map tool.

5.5.7 The Bioanalyst who performed the mapped decision will inform other team members via email including the manager or Senior Bioanalyst of the specific project that the new data is available. The data is registered so that the Sy/Map data viewer can be used for review. The location of the dataset is also sent to other users in case the SAS Viewer is a preferred form of review.

5.6 Coding Reporting Update

5.6.1 On a monthly basis, the Bioanalyst will perform a coding and reporting update.

5.6.1.1 The Bioanalyst updates the source data sets for the specified study. The Bioanalyst will meet with the data manager if the data is not retrievable.

5.6.1.2 The Bioanalyst modifies a template program to perform the adverse event coding.

5.6.1.3 An Adverse Event Coding Session Form is filled out to document the source data along with other coding verification tasks.

5.6.1.4 The Bioanalyst sends this form along with the mapped data and reports to the biostatistician or the customer that has requested this data.

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