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How to Register Industrial and Other Trials

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

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    titleYou 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.

  2. Select or enter In the various fields, specify the appropriate information in the text fields and drop-down lists. Fields are described in the following table. The following table describes the fields.

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    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 trials

    Field Label

    Description/Instructions

    Various

    Select or enter In the various fields, specify the appropriate information in . The following sections describe the text fields and drop-down lists as appropriate according to the detailed instructions provided for each of the following sections:

    Save as Draft

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    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.

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

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How to Complete the Trial Identifiers Section
Select or enter In the various fields, specify the appropriate information in . The following procedure describes the text fields and drop-down lists. Fields are described in the following table. All fields except the ClinicalTrials.gov Identifier are required.

  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).

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How to Complete the Trial Details Section

Select or enter In the various fields, specify the appropriate information in the text fields and drop-down lists. Fields are described in the following table. The following table describes the fields. An asterisk (*) indicates a required field.

Instructions for recording Trial Details

Field LabelDescription/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 the default).

Primary Purpose*

1. Select the primary reason for conducting the trial. The following list provides valid values.

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2. If the primary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.

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The text field is displayed only after you have selected Other.

Secondary Purpose

1. Select one of the following reasons for conducting the trial.

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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.

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Trial Phase Values - Include 20170406

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.

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How to Complete the Trial Details Section

Select or enter In the various fields, specify the appropriate information in the text fields and drop-down lists. Fields are described in the following table. The following table describes the fields. An asterisk (*) indicates a required field.

Instructions for recording Trial Details

Field LabelDescription/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:

  1. Observational. Studies among cancer patients and healthy populations that involve no interventions or alteration of the participants.
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Primary Purpose*

1. Select the primary reason for conducting the trial from the following values.

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Primary Purpose Values - Include 20170406

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.

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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.

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2. If the study model is Other, type a detailed description of the trial’s study model in the text field provided.

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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.

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2. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided.

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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.

Info

Select N/A for observational and ancillary-correlative trials.

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Trial Phase Values - Include 20170406

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 .

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How to Complete the Status/Dates Section

Select or enter In the various fields, specify the appropriate information in the text fields and drop-down lists. Fields are described in the following table. The following table describes the fields. An asterisk (*) indicates a required field.

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.

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