This section provides instructions for registering Industrial and other (e.g., Consortia) trials in the CTRP via the Registration user interface.
About Industrial and Other Trial Registration
Although Registration users can register Industrial/Other trials in the CTRP by importing them from ClinicalTrials.gov, they can not do so without entering a ClinicalTrials.gov ID. You can register trials without ClinicalTrials.gov identifiers directly, using a CTRO-restricted feature in Registration. The CTRP designates the trials you register as Abbreviated trials, assigns them the processing status Submitted, and assigns them an NCI ID.
Before you begin
Log in to the NCI CTRP Registration application in addition to Protocol Abstraction.
How to Register Industrial and Other Trials
On the main menu, click Register Industrial/Other Trial.
The Register Trial page in Registration appears.You can expand and collapse sections of the registration page
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.
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.
Tip
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.
Instructions for registering trialsField Label
Description/Instructions
Various
Select or enter the appropriate information in the text fields and drop-down lists as appropriate according to the detailed instructions provided for each of the following sections:
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. - Correct any errors if indicated, and repeat the previous steps as many times as necessary until the trial is error-free.
Recording Trial Identification Information
How to Complete the Trial Identifiers Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. All fields except the ClinicalTrials.gov Identifier are required.
- Click Please Select the Lead Organization.
A list of organizations that are principal administrative organizations responsible for the study appears. - Select the organization from the list.
- If the lead organization is not listed, click Search, and follow the instructions in Searching for Organizations.
- 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
- Click Please Select Submitting Organization.
A list of affiliated organizations appears. - Select the organization from the list.
- If the submitting organization is not listed, click Search, and follow the instructions in Searching for Organizations.
- Enter the Submitting Organization Local Trial Identifier exactly the same as it appears in the protocol document.
Optionally, enter the number assigned to the trial by PRS (ClinicalTrials.gov).
When you submit the trial, the system checks the NCT number you entered to ensure that no other registered trial has the same one. The system displays an error message if it finds another trial with the same NCT number. If this occurs, check the number you entered and try again. If you are certain that the number you entered is correct, contact the CTRO at NCICTRO@mail.nih.gov.
Recording Interventional Trial Details
How to Complete the Trial Details Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. All fields other than Secondary Purpose are required.
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) | |||||||||||||||||||||||||||
Trial Type | Select Interventional (the default). | |||||||||||||||||||||||||||
Primary Purpose | 1. Select the primary reason for conducting the trial. The following list provides valid values. Unable to render {include} The included page could not be found. 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. When you specify trial data in CTRP, the system requires you to specify the phase of investigation, as defined by the US FDA for trials involving investigational new drugs. The following table provides a definition of each phase and maps the ClinicalTrials.gov values to the CTRP 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. |
Recording Non-Interventional Trial Details
How to Complete the Trial Details Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. All fields are required.
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. | |||||||||||||||||||||||||||
Trial Type | Select Non-Interventional. | |||||||||||||||||||||||||||
Non-Interventional Trial Type | Select one of the following trial types:
| |||||||||||||||||||||||||||
Primary Purpose | 1. Select the primary reason for conducting the trial from the following values. Unable to render {include} The included page could not be found. 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. When you specify trial data in CTRP, the system requires you to specify the phase of investigation, as defined by the US FDA for trials involving investigational new drugs. The following table provides a definition of each phase and maps the ClinicalTrials.gov values to the CTRP 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 search for the principal investigator. See Looking Up Registered Persons . |
Recording Data Table 4 Information
The Trial Submission Category is preselected for you.
How to Complete the Data Table 4 Information Section
- Click Please Select the Data Table 4 Sponsor Organization.
A list of organizations appears. Select the organization from the list.
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.
To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary.
- The Industrial? field defaults to Yes. If the trial is not Industrial, select No - National, No - Externally Peer-Reviewed, or No - Institutional.
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Recording Site-Specific Recruitment Statuses and Dates
Current trial status definitions
# | CTRP Trial Status Values | ClinicalTrials.gov Trial Status Values | Status Category | Definition |
---|---|---|---|---|
01 | In Review | Not yet recruiting | Review | Participants are not yet being recruited. |
11 | Withdrawn | Withdrawn | Terminal | Study halted prematurely, prior to enrollment of first participant. |
02 | Approved | Not yet recruiting | Review | Participants are not yet being recruited. |
03 | Active | Recruiting | Open | Participants are currently being recruited, whether or not any participants have yet been enrolled. |
04 | Enrolling by Invitation | Enrolling by Invitation | Open | Participants are being (or will be) selected from a predetermined population. |
08 | Temporarily Closed to Accrual | Suspended | Open | Study halted prematurely but potentially will resume. |
09 | Temporarily Closed to Accrual and Intervention | Suspended | Open | Study halted prematurely but potentially will resume. |
05 | Closed to Accrual | Active, not recruiting | Closed | Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. |
06 | Closed to Accrual and Intervention | Active, not recruiting | Closed | Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. |
10 | Administratively Complete | Terminated | Terminal | Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. |
07 | Complete | Completed | Terminal | The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred). |
How to Complete the Status/Dates Section
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. Items with an asterisk are required fields.
Instructions for recording Site Recruitment Statuses/Dates
Field Label | Description/Instructions |
---|---|
Site Recruitment Status* | Select the current stage or state of the trial or study. |
Site Recruitment Status Date* | Enter the date on which the current trial status became effective. See Trial Status Rules. |
Date Opened for Accrual | If appropriate, enter the date on which the trial was opened for accrual. |
Date Closed for Accrual | If appropriate, enter the date on which the trial was closed for accrual. |
Submitting Trial-Related Documents
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.
Special processing for PDF files
Adobe PDF files require special processing. Please see the information about creating PDFs in Converting Documents to PDFs .
How to Submit Trial Related Documents
- Next to the document-type field, (e.g., IRB Approval), click Browse.
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."
Repeat the steps above for each type of document.
Adding Multiple "Other" Documents
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
Trial-related documents uploaded as Microsoft Word (.doc), Microsoft Excel (.xls, .xlsx, .xlsm, or .xlsb), and WordPerfect files contain text that abstractors can copy and paste directly. PDFs (portable document format) contain text that abstractors can copy only if the content was created from other text-based applications such as Word or Excel.
Abstractors can not copy and paste text from scanned documents
Avoid uploading PDFs of scanned documents. They can not be edited, copied, or read with OCR (optical character recognition) applications.
Microsoft provides instructions for converting files to PDFs both on their website and in the Help documentation in each of its applications.
When searching for help, use "save file as pdf" as the search term.
You do not need a document converter in Mac OSX. Instead, print your documents to a PDF file.
How to Convert Text-Based Files to PDFs in Mac OSX
- Open your text file in its original format (such as .doc or .xls).
- Click File > Print.
- In the Print window, click the PDF button at the bottom-left and select the Save as PDF option.
- Choose the file location, rename your PDF file, and then click Save.