CRFS | CTC | Treatment | Subgroup | Registering | Group | Therapy | Disease | Tips

The CTMS Case Report Forms include a number of new fields into which "codes" are to be entered. NCI/CTEP, the IND sponsor of the CTMS-monitored trials, intends to be able to cross-summarize data more consistently and reliably.

The code-fields are inherited from CTEP’s Clinical Data Update System (CDUS). Although investigators with CTMS-monitored protocols do not need to make CDUS submissions themselves, all the same data is needed, and so CTMS has had to augment its CRFs with these new fields.

The major code fields are the CTC code for Adverse Events, the Treatment Assignment Code (TAC) for dose levels, and the Subgroup code for patient stratification. Additional codes have been added for institutions, groups, agents, and diseases.

Version 2 of the Common Toxicity Criteria (CTC2) is the mandated standard for evaluating adverse events for all protocols initiated since March 1998. Protocols approved from October 2003 will use the new standard Common Terminology Criteria for Adverse Events version 3 (CTCAE3 or CTC3) Information about CTC2 and CTC3 can be found on the CTEP website: http://ctep.cancer.gov. While the primary purpose of the CTC is to standardize the grading of toxicities, CTEP has decided that it also provides a basis for categorizing and summarizing incidence rates.

The CTC documentation does not include useful terms for concisely reporting the category of an adverse event. Instead, it is written using long descriptive passages. Consequently, CTMS decided to ask that the term be specified using the code lists which CTEP developed for its Clinical Data Update System (CDUS). These can be accessed on the CTEP website by following the "List of Codes and Values" link. For ready reference, these code lists been compressed onto inserts in the CTMS CRF manual and onto stiff coding charts. Users of ACES® will find it built into a "pick list" that will pop up on the CTC code entry field.

This was introduced to provide a concise and consistent way of describing the regimen and dose level of the experimental drugs administered. CTMS continues to capture the actual regimen via the "arm" and the actual drug administration dosages, but, in addition, the appropriate TAC must be indicated for each course. The TACs are required by the CDUS, so that CTEP can summarize and cross-tab the study data. The CDUS maintains an associated table of "Treatment Assignment Descriptors" which allow it to display its tabulations back in English.

Each protocol has its own TAC code list. CTEP (the Pharmaceutical Management Branch) determines what TACs are to be used while it reviews the protocol. Accompanying each protocol approval letter, there is a letter from the Protocol Information Office (PIO) which lists these codes and their descriptions. The investigator is responsible for conveying the list to the data management staff. If you cannot locate the TAC code list for a protocol, you can call PIO or send an email request to the CTEP helpdesk CTEPhelpdesk@ctep.nci.nih.gov.

This was introduced by CTEP/CDUS to capture information about the assignment of patients to study analysis strata, e.g. by age and/or sex and/or prior treatment, etc. Since the number and nature of these factors varies among protocols, CTEP/CDUS decided a single code field would be used.

The TACs are determined by CTEP after reading the protocol and are sent out along with the TAC code list. Most CTMS-monitored protocols are Phase I studies with no subgroup analysis of the patients. In this case, CDUS generally assigns the code "SG1" to be entered for all patients. If you cannot locate the Subgroup list for a protocol you can call PIO or send an email request to the CTEP helpdesk.

CTEP wants to know precisely which institution registers each patient, and the treating institution, if it is different. To be able to match up accrual, or other factors, across all protocols, the CDUS requires this to be specified using the code assigned in a large master list maintained by CTEP. For institutions in the United States, the code consists of the 2 letter postal abbreviation (NY, NY, CA, etc.) followed by three digits. The codes for institutions outside the United States are 5 digit numbers, with the first two indicating the country. The list can be accessed on the CTEP website in "List of Codes and Values" section. If you cannot view this list, or if your institution is missing, call PIO or email the CTEP Help Desk and they will assist you.

For inter-group trials only, CTEP wants to know which group is registering the patient. The CDUS has established a short list of codes for the groups, generally the acronym. This can be accessed on the CTEP website in the "List of Codes and Values" section. If you cannot view this list, call PIO or email the CTEP Help Desk and they will assist you.

CTEP also wants to be able to summarize and cross-tab study data based on prior therapies which a patient may have received. To this end, the CDUS has established categories into which all therapies can be grouped, and assigned a code to each. Since the CTMS Prior Treatment Summary Case Report Form contains a check-off for each category, this is one code list that you do not have to go to CTEP for.

CTMS has always collected the Primary Site of disease and the Histology for each patient, but these have been free text fields and hence are hard to summarize or correlate. CTEP has asked for more precise disease categorization, and so the CDUS now requires the provision of a specific code number from a code list. This can be accessed on the CTEP website in the "List of Codes and Values" section. This list is very long and detailed. If you cannot view this list or if you cannot make a choice, call PIO or email the CTEP Help Desk and they will provide the appropriate code.

Some of the code lists are stored on the CTEP website as "plain text" (.txt) files, some as Adobe Acrobat® (.pdf) files, and some are available in both formats. If you click on the download icon for a ‘txt’ file, it will probably simply open up in your browser window, from which you can print it. What you do to actually download and save a local copy depends on your browser: in Microsoft Internet Explorer, Right-click on the icon and select "save target as" and then point to a directory; in Netscape Navigator, Shift-Left-click on the icon and select "save as" and then point to a directory. You can open the saved file in the Windows Notepad to view or print the code list.

To view an Acrobat file you need to have a copy of the Acrobat Reader installed on your PC. This is free software; there is a link to the download site at the bottom of the CTEP website "Informatics" page. Generally when you click on a ‘pdf’ download the Acrobat Reader will open a secondary toolbar in your browser window and then open the document. From the toolbar you can print the file, or save it locally. Sometimes when the Reader is installed it does not integrate itself this way with the browser. In this case, clicking on the icon will bring up a ‘save’ dialog, and you must separately launch Acrobat and open the saved file.

CRFS | CTC | Treatment | Subgroup | Registering | Group | Therapy | Disease | Tips