Log in to the NCI CTRP Registration application in addition to Protocol Abstraction.

How to Register Industrial and Other Trials

1. On the main menu, click Register Industrial/Other Trial. The Register Trial page in Registration appears.

   Screenshot TBD.

   By default, all sections of the registration form are displayed.  To collapse or  expand each section individually, click the Collapse or Expand icon on the right side of the section title as shown in the figure above. To collapse all sections, click Collapse All.

2. In the various fields, specify the appropriate information. The following sections describe the fields:

   • Recording Trial Identification Information
   • Recording Intervention Trial Details
   • Recording Non-Intervention Trial Details
   • Recording Data Table 4 Information
     
   • Recording Site Recruitment Statuses and Dates
   • Uploading Trial-Related Documents

   Be sure to provide information for all fields marked with an asterisk (*). If you cannot complete the registration of a trial in one Registration session, you can save a draft of the trial details you have completed. Later you can return to complete the registration in another session.

3. At any time while specifying trial information, consider using one of the buttons described in the following table:

   Instructions for registering trials

   Field Label	Description/Instructions
   Save as Draft	Click to save a draft of the record so that you can complete the registration at another time. You must have provided, at the minimum, both the Lead Organization and Lead Organization Trial Identifier to save a draft. The system saves your draft, assigns it a unique ID (for tracking purposes), and sends you an email message confirming that the information has been saved. You can end your CTRP Registration Site and retrieve your draft later to complete the registration.
   Review Trial	Click to initiate the system check for errors and missing information. The system displays the results in a message at the top of the Review Trial Details page. Indicators mark specific fields that you must complete or correct in order to submit the trial. The Review Trial Details page is read-only. To make changes to the trial data, follow the instructions in Recording Trial Details.
   Cancel	Click to cancel the registration. A pop-up message prompts you to confirm cancellation. If you choose to cancel the registration, you will lose all data that you may have entered.

4. Correct any errors if indicated, and repeat the previous steps as many times as necessary until the trial is error-free.

1. Click Please Select the Lead Organization.
   A list of organizations that are principal administrative organizations responsible for the study appears.
2. Select the organization from the list.
3. If the lead organization is not listed, click Search, and follow the instructions in Searching for Organizations.
4. Enter the Lead Organization Trial Identifier, the unique identification used to identify, name, or characterize the protocol document, exactly the same as it appears in the protocol document. For Inter-Group trials, type the Lead Group's trial number. For multi-site trials that have no assigned single center, use the protocol ID.
   Example: NSABP-B-40
5. Click Please Select Submitting Organization.
   A list of affiliated organizations appears.
6. Select the organization from the list.
7. If the submitting organization is not listed, click Search, and follow the instructions in Searching for Organizations.
8. Enter the Submitting Organization Local Trial Identifier exactly the same as it appears in the protocol document.

9. Optionally, enter the number assigned to the trial by PRS (ClinicalTrials.gov).

   

In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

Instructions for recording Trial Details

Field Label	Description/Instructions
Title*	Enter the official name of the protocol provided by the study principal investigator or sponsor. (Limit 4000 characters) For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"
Trial Type*	Select Interventional (the default).
Primary Purpose*	1. Select the primary reason for conducting the trial. The following list provides valid values. 2. If the primary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided. The text field is displayed only after you have selected Other.
Secondary Purpose	1. Select one of the following reasons for conducting the trial. 2. If the secondary purpose is Other, enter a detailed description of the trial’s secondary purpose in the text field provided.
Phase*	Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. The following list provides valid values.
Is this a Pilot?	Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial.
Site Principal Investigator*	Click Look Up Person and follow the instructions in Looking Up Registered Persons to select the site principal investigator.

In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

Instructions for recording Trial Details

Field Label	Description/Instructions
Title*	Enter the official name of the protocol provided by the study principal investigator or sponsor. For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"
Trial Type*	Select Non-Interventional.
Non-Interventional Trial Type*	Select one of the following trial types: Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants.
Primary Purpose*	1. Select the primary reason for conducting the trial from the following values. 2. If your trial does not fall into one of these categories, select Other, and note the type of trial in the corresponding text box. The text box is displayed only after you have selected Other.
Study Model Code*	1. Select the primary strategy for subject identification and follow-up. The following list provides valid values. 2. If the study model is Other, type a detailed description of the trial’s study model in the text field provided. The text field is displayed only after you have selected Other.
Time Perspective Code*	1. Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values. 2. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided. The text field is displayed only after you have selected Other. The limit is 200 characters; the system counts down the character numbers as you type.
Phase*	Select the phase or stage of the clinical trial as defined by the US FDA, from the drop-down list. The following list provides valid values. Select N/A for observational and ancillary-correlative trials.
Is this a Pilot?	Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial.
Site Principal Investigator*	Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons .

How to Complete the Data Table 4 Information Section

1. Click Please Select the Data Table 4 Sponsor Organization.
   A list of organizations appears.

2. Select the organization from the list.

3. If the sponsor organization is not listed, click Search, and follow the instructions in Searching for Organizations.
   The organization you selected is displayed along with an option to delete it.

   A trial can have multiple sponsors. Repeat the steps above to add other sponsors.

4. To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary.

5. The Industrial? field defaults to Yes. If the trial is not Industrial, select No - National, No - Externally Peer-Reviewed, or No - Institutional.

In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

Instructions for recording Site Recruitment Statuses/Dates

When registering Abbreviated trials, you upload the following types of documents:

• IRB Approval

• Informed Consent

  Upload your documents as Microsoft Word (.doc, .docx, or .docm), Adobe PDF, or WordPerfect files.

1. Next to the document-type field, (e.g., IRB Approval), click Browse.

2. Navigate to, and select, the appropriate document, and then click Open.

   Depending on your operating system, you may see a different command name for "Open."

3. Repeat the steps above for each type of document.

   You can upload more than one (1) "Other" document. After you have uploaded the first of your "Other" documents, click the Add More link. A new Other document field is displayed.

Converting Trial-Related Documents to PDF Format