 |
Page History
...
| width | 40% |
|---|
...
| Panel | ||||||
|---|---|---|---|---|---|---|
| ||||||
|
...
| Tip | ||
|---|---|---|
| ||
The system logs you off if it detects that you have not used the application for 90 minutes. |
| Tip |
|---|
The system locks you out after three unsuccessful attempts to log in within 24 hours. In the event that you have been locked out of your account, contact CBIIT Application Support at ncicbiit@mail.nih.gov , or phone: 240-276-5541 or toll free: 888-478-4423. If you have forgotten your password, see Resetting Your NCI Password . |
About Trial Registration
The way in which you register trials in the CTRP depends on a combination of the trial's Data Table 4 Categorization as either Complete or Abbreviated , your affiliated organization and its role in the trial, and whether the trial currently is registered in ClinicalTrials.gov with an NCT ID.
...
Guidelines for Complete Trials
If your trial is Complete, follow the instructions in Registering New Complete Trials.
- Cancer Center trials must meet the following criteria to be eligible for registration:
- Trials must have been active as of January 1, 2009 or any time thereafter.
- Submitting organization is the Lead Organization or the Coordinating Center.
- CTEP or DCP PIO-managed trials must meet the following criteria to be eligible for registration:
- If NCI-managed, trials must have been active as of January 1, 2009 or any time thereafter.
If NCI-sponsored, trials either must have been Completed as of December 2007 or opened anytime thereafter).
Note Cancer Centers do not register PIO-managed trials. These trials are submitted to CTRP directly by CTEP and DCP.
Guidelines for Abbreviated Trials
...
If your trial is Abbreviated, registration differs according to a combination of the following trial attributes:
- NCT ID (which indicates that the trial has been registered with ClinicalTrials.gov)
- Cancer Center type (NCI-designated Cancer Centers or other centers)
- NCI grant
- Lead organization
Guidelines for Trials with NCT IDs
If the trial is an Industry funded trial, and has an NCT ID, then it can be imported into CTRP from ClinicalTrials.gov in most cases. In some special cases, however, the trial cannot be imported directly and instead you must contact the CTRO for assistance.
- If your organization is not an NCI-designated Cancer Center organization, NIH institute, or pharmaceutical company, you will need to import the trial directly from ClinicalTrials.gov. Instructions for this process can be found under Registering Abbreviated (Industrial and Other) Trials.
| Info |
|---|
The system assigns the trial you import from ClinicalTrials.gov the Data Table 4 Category (funding source) Industrial/Other. To specify whether the trial is Industrial, or to specify if an Other trial is National or Externally Peer-Reviewed, contact the CTRO for assistance at ncictro@mail.nih.gov. For funding source definitions, see http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4. |
- If your organization is the Lead Organization on a trial, and your organization is an NCI-designated Cancer Center organization, do not import the trial from ClinicalTrials.gov. Instead, submit the trial to CTRP as a Complete trial, as described in Registering New Complete Trials.
- If your organization is the Lead Organization for any trial on anything other than an NCI-designated Cancer Center organization, NIH institute, or pharmaceutical company trial, the CTRO contacts the Center and further categorizes the trial as Other/National or Other/Externally Peer-Reviewed based on whether your trial is conducted under an NIH grant, as follows:
- If your trial is conducted under an NCI grant, the CTRO categorizes it as a Consortia trial.
- If your trial is not conducted under an NCI grant, the CTRO categorizes it as follows:
- Other/National, for trials sponsored by an NIH institute
- Other/Externally Peer-Reviewed, for trials managed by a hospital or a center other than one designated by the NCI
Guideline for Trials without NCT IDs
If your trial is Abbreviated but does not have an NCT ID, please contact the CTRO for assistance at ncictro@mail.nih.gov. CTRO registers these trials manually.
Registering New Complete Trials
...
| MultiExcerptName | submittrial |
|---|
| Info |
|---|
Before you begin to register a trial, ensure that the trial does not exist in the system already by searching for trials using any of the criteria as per the instructions in Searching for Trials . The system uses the Lead Organization ID, Lead Organization Trial ID, and the ClinicalTrials.gov Identifier to detect duplicates. If a duplicate is detected, the system will not record your trial. |
How to Register New Complete Trials
On the toolbar, click Register Trial, and select your trial's Submission Category (funding source) from the drop-down list, either National, Externally Peer-Reviewed, or Institutional.
| Tip |
|---|
To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, click the Help icon ( |
...
The system can create an XML document that is formatted to facilitate trial registration with ClinicalTrials.gov. The document it creates contains all the information that you submit during registration and all the trial data abstracted by the CTRO. If you indicate that you do not need to register the trial with ClinicalTrials.gov, you will not be asked to provide regulatory and responsible party information.
| Tip | ||
|---|---|---|
| ||
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 figures below. 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 Complete trials
...
XML required. Enable "Upload from NCI CTRP" in ClinicalTrials.gov?
...
If you require an XML document to register your trial with ClinicalTrials.gov, select Yes.
If you are not going to submit your trial to ClinicalTrials.gov, select No.
The option you select here dictates which sections you will be required to complete. For example, if you select No, you will not be required to complete responsible party and regulatory information. If you select Yes, NCI will be added as a collaborator to the Funding Source.
...
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:
- Recording Trial Identification Information
- Recording Interventional Trial Details
- Recording Non-interventional Trial Details
- Recording Lead Organizations and Principal Investigators
- Recording Sponsors and Responsible Parties
- Recording Data Table 4 Information
- Recording NIH Grants
- Recording Trial Statuses
- Recording Trial Dates
- Recording INDs and IDEs
- Recording Regulatory Information
- Recording Trial-Related Documents
...
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 Registration session 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 Interventional Trial Details and Recording Non-Interventional Trial Details .
...
Click to cancel the registration. A pop-up message prompts you to confirm cancellation.
| Note |
|---|
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.
...
To continue with the trial registration, scroll to the bottom of the Review Trial Details page, and then click Submit. To prevent creating a duplicate record, do not click Submit more than once. If you have to make changes after you click Submit, contact the CTRO at ncictro@mail.nih.gov rather than using your browser's Back button to make changes.
The registration notification message system sends you an email message to acknowledge that the trial has been submitted. Later it sends another email message to notify you when your trial has been accepted or rejected.
| Info |
|---|
After submission, most users other than the trial submitter can not see the trial information you provided until the information has been validated. However, an organization administrator (if one exists) and an assigned owner can access the information prior to validation. |
Recording Trial Identification Information
...
| MultiExcerptName | submittrialid |
|---|
...
How to Complete the Trial Identifiers Section
...
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field.
...
Field Label
...
Description/Instructions
...
Lead Organization Trial Identifier*
...
Enter the unique identification assigned to the protocol by the sponsoring organization, exactly 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, for example, NSAGP-B-40.
...
ClinicalTrials.gov Identifier
If the trial has been submitted to ClinicalTrials.gov previously, enter the number assigned to the trial by PRS (ClinicalTrials.gov).
| Note |
|---|
The CTRP renamed the previous identifiers "NCT Number" and "NCT ID" to "ClinicalTrials.gov Identifier". |
| Note |
|---|
You cannot change the ClinicalTrials.gov Identifier once you have added it. If you need to make changes thereafter, contact the CTRO at NCICTRO@mail.nih.gov. |
...
Other Trial Identifier
...
Enter an additional trial identifier such as unique identifier from other registries, NIH grant numbers, or protocol numbers assigned by the Review Board, and then click Add Other Identifier. Repeat this step for each additional identifier.
The ID you added is displayed in the Other Identifier list.
To delete an identifier you have added, in the Action Column, click Delete.
Recording Interventional Trial Details
...
| MultiExcerptName | submitrialtitle |
|---|
...
How to Complete the Trial Details Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Interventional 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"
...
Phase*
...
Is this a Pilot?*
| Info |
|---|
This field is displayed only if you selected NA from the Phase drop-down list. |
...
...
Trial Type*
...
Select the trial type indicated in the protocol. Interventional is the default.
...
Primary Purpose*
Select the primary reason for conducting the trial. The following list provides valid values.
...
| Info |
|---|
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. |
...
Select one of the following reasons for conducting the trial.
...
Click to select the disease terminology used to report subject accruals for this trial.
Recording Non-Interventional Trial Details
...
| MultiExcerptName | submittrialnoninterventional |
|---|
...
How to Complete the Trial Details Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section 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.
For example: "Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the Prostate"
...
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. |
...
Is this a Pilot?*
| Info |
|---|
This field is displayed only if you selected NA from the Phase drop-down list. |
...
Trial Type*
...
Select the trial type. Non-Interventional is selected by default.
...
Select one of the following trial types:
...
Primary Purpose*
Select the primary reason for conducting the trial. The following list provides valid values.
...
| Info |
|---|
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. |
...
Study Model Code*
Select the primary strategy for subject identification and follow-up. The following list provides valid values.
...
| Info |
|---|
The text field is displayed only after you have selected Other. |
...
Time Perspective Code*
Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.
| Include Page |
|---|
...
| Info |
|---|
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. |
...
Site Principal Investigator*
...
Click Look Up Person and search for the principal investigator. See Looking Up Registered Persons .
Recording Lead Organizations and Principal Investigators
...
| MultiExcerptName | submittrialleadorganization |
|---|
...
The Lead Organization is the institution that is the principal administrative organization responsible for the study. Each trial can have one Lead Organization only.
You must complete both fields in the Lead Organization/Principal Investigator section.
| Tip | ||
|---|---|---|
| ||
The Principal Investigator is the individual who is responsible and accountable for conducting the clinical trial. The PI assumes full responsibility for the treatment and evaluation of human subjects, and for the integrity of the research data and results. |
...
- Next to the Lead Organization field, click Please Select the Lead Organization.
The system displays your affiliated organization first, followed by affiliated organization family members. Organizational roles are displayed when applicable.
- Select the appropriate organization from the list. If the organization is not listed, click Search, and search for the organization as per the instructions in Looking up Registered Organizations .
- If the search does not return your trial's lead organization, you can register it in the system at this point. To register an organization, follow the instructions in Adding Organizations to the CTRP.
- Next to Principal Investigator click Look Up Person, and search for the principal investigator as per the instructions in Looking Up Registered Persons.
- If your trial's principal investigator's name is not listed, you can register it in the system at this point. To register an investigator, follow the instructions in Adding Persons to the CTRP.
Recording Sponsors and Responsible Parties
...
| MultiExcerptName | submittrialsponsor |
|---|
...
Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.
| Tip |
|---|
The system will not display this section unless you indicate that you require an XML document. |
The Responsible Party can be either a sponsor, principal investigator (PI), or sponsor/investigator. The term "responsible party" is either of the following:
- Sponsor. Name of the primary organization that oversees the implementation of the study and is responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3.
- or - - Principal Investigator. The individual who serves as the principal investigator and is designated as responsible party, consistent with the conditions described in the statute.
- or - - Sponsor-Investigator: The individual who both initiates and conducts the study.
| Info |
|---|
For further elaboration on the definition of these roles with respect to responsible party, see http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf. |
You must complete all fields in the Sponsor/Responsible Party section. The fields displayed depend on your selection of the Responsible Party role, as shown in the images below.
If you select Sponsor (above), you do not submit any further information about the Responsible Party.
If you select Principal Investigator (above), this section expands to display the investigator's title and organization affiliation. The system populates the Investigator's Name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.
If you select Sponsor-Investigator (above), this section expands to display the investigator's title and organization affiliation. Although the system populates the Investigator's name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section, you can select another person for this role.
| Tip |
|---|
Before you begin, complete the Lead Organization/Principal Investigator section. Doing so will ensure that the Sponsor/Responsible party section is pre-populated when applicable. |
How to Complete the Sponsor/Responsible Party Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section are required.
...
Field Label
...
Description/Instructions
...
Sponsor*
...
Click Look Up Sponsor and search for the organization as per the instructions in Looking Up Registered Organizations.
...
Responsible Party*
...
Indicate the party who is responsible for the trial. Select one of the following options:
Sponsor. Name of primary organization that oversees implementation of study and is responsible for data analysis. If you select this role, you do not submit any further information about the Responsible Party.
- Principal Investigator. Primary medical researcher in charge of carrying out a clinical trial's protocol. If you select this role, this section expands to display the investigator's title and organization affiliation. The system populates the Investigator's Name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.
- Sponsor-Investigator. The individual who both initiates and conducts the study. If you select this role, this section expands to display the investigator's title and organization affiliation. The system populates the Investigator's Name field with the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section.
...
Investigator*
...
If the Responsible Party is the Principal Investigator, you can not change the person's name.
If the Responsible Party is the Sponsor-Investigator, you can change the person's name. To do so, click Look Up Sponsor, and follow the instructions in Looking Up Registered Persons .
...
Investigator Title*
...
The system populates this field. Enter a new title in the field provided if other than Principal Investigator.
Investigator Affiliation*
...
If the Responsible Party is the Principal Investigator, you can change the affiliated organization. To do so, click Look Up Organization, and follow the instructions in Looking Up Registered Organizations.
If the Responsible Party is the Sponsor-Investigator, you can not change the affiliated organization.
Recording Data Table 4 Information
...
| MultiExcerptName | submittrialfunding |
|---|
...
Complete all fields in the Data Table 4 Information section. The Trial Submission Category (study source) or Data Table 4 Funding Sponsor Type fields are pre-populated with the sponsor type.
| Info |
|---|
The lead organization or at least one participating site must be a Cancer Center organization. |
How to Complete the Data Table 4 Information Section
...
To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary.
If you have selected a lead organization for the trial and if that lead organization belongs to an organization family, the Program Code field is available. The Program Code field lists all program codes available for that organization family. If you are a site administrator, an option to manage program codes is also available.
...
- Retrieve that draft trial for completion, return to this Data Table 4 Information section, and click Manage Program Codes.
- On the toolbar, click Administration > Program Codes > Manage Master List.
Recording NIH Grants
...
| MultiExcerptName | submittrialgrant |
|---|
...
This section pertains to Complete trials. You must record NIH grant information for your trial, including the funding mechanism, institute code, serial number, and NCI division/program. You can add up to five NIH grants.
| Info |
|---|
| If the Lead Organization for the trial is a Cancer Center organization, you must record a valid P30 grant. |
For a complete guide to NIH grant information, see the Grants and Funding page at http://grants.nih.gov/grants/funding/funding_program.htm.
How to Complete the NIH Grant Information Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section are required if your study is funded by NIH.
Instructions for recording NIH Grant Information
...
Field Label
...
Description/Instructions
...
Funding Mechanism
...
Enter the initial letter(s) and or number(s) in the Funding Mechanism field and then select the NIH unique identifier from the drop-down list. The funding mechanism is a 3-character code used to identify areas of extramural research activity applied to funding mechanisms.
| Tip | ||
|---|---|---|
| ||
Click the down arrow in the field, and then use the up and down arrow keys on your keyboard to scroll up and down the drop-down list. When you arrive at the appropriate code, press the ENTER key. |
For a list of valid codes, see Funding Mechanism Codes.
...
Institute Code
...
Serial Number
...
Enter the five- or six-digit number generally assigned sequentially to a series within an Institute, Center, or Division, for example, 123660. If you selected CA in the Institute Code field, the system displays the top ten grants that match the sequence of serial numbers as you type them one-by-one. By selecting a grant from the list, you ensure that you record a valid serial number.
...
NCI Division/Program Code
...
Enter the initial letter(s) of the division or program code, and then select the code for the organizational unit that provides funding for the study, from the drop-down list.
For a list of Division and Program Codes, see NCI Division and Program Codes .
Click Add Grant.
| Info |
|---|
The Add button is operable only after you have provided the grant information in all fields. |
...
...
Recording Trial Statuses
...
| MultiExcerptName | submittrialstatus |
|---|
...
Valid trial statuses used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. ClinicalTrials.gov status definitions are provided in Trial Status Values in the CTRP and ClinicalTrials.gov.
| Note | ||
|---|---|---|
| ||
The system validates each new status as you add it, as well as when you review the trial information before submitting the trial for registration. |
...
|
...
How to Complete the Trial Status Section
...
Click Add Status.
The new status record is displayed.
...
- To edit the status, in the Actions column, click the Edit icon and make changes as indicated in the Error and/or Warning message.
- To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the record, and then add the correct status information.
...
|
...
Trial Status Transitions
...
...
Recording Trial Dates
...
| MultiExcerptName | submittrialdate |
|---|
...
|
...
How to Complete the Trial Dates Section
- Select or enter the appropriate information in the text fields and drop-down lists. An asterisk (*) indicates a required field.
- Indicate whether the dates you entered are Actual or Anticipated.
...
Recording INDs and IDEs
...
| MultiExcerptName | submittrialind |
|---|
...
Enter the IND/IDE number and grantor fields only if your trial is/was conducted in the United States. You must indicate whether your trial qualifies as an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) protocol.
There are several dependencies between elements in the IND/IDE section. Follow the instructions below in the order in which they are presented.
How to Register IND/IDE Trials
Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.
Instructions for recording IND/IDE Information
...
Field Label
...
Description/Instructions
...
IND/IDE Types*
...
If the trial involves an Investigational New Drug Application, select IND. If the trial involves an Investigational Device Exemption, select IDE.
...
IND/IDE Number*
...
Enter the number assigned to an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)
| Tip | ||
|---|---|---|
| ||
You can enter the IND number in many formats. For example, for a biologics (BB) IND that contains the number 1234, you can type BB1234, 1234, or BB_1234. |
...
IND/IDE Grantor*
...
Select one of the following organizations that holds the IND/IDE approval:
- For IND trials:
- Center for Drug Evaluation and Research
- Center for Biologics Evaluation and Research
- For IDE trials:
- Center for Devices and Radiological Health
- Center for Biologics Evaluation and Research
...
IND/IDE Holder Type*
...
Select one of the following holder types:
- Investigator
- Organization
- Industry
- NIH
- NCI
...
NIH Institution, NCI Division/Program Code* (required if the holder type is NIH or NCI)
Select a code from the drop-down list.
...
Expanded Access?
...
If an experimental drug or device is available outside any clinical trial protocol, select Yes.
...
Expanded Access Type* (required if you selected the Yes check box in the Expanded Access? column)
...
Select one of the following access types:
- Available - Expanded access is currently available for this treatment
- No Longer Available - Expanded access was available for this treatment previously but is not currently available and will not be available in the future
- Temporarily not available - Expanded access is not currently available for this treatment, but is expected to be available in the future
- Approved for Marketing - This treatment has been approved for sale to the public
...
Exempt?
...
Select the Yes check box in the Exempt? column if the investigational product does not require FDA approval .
...
Recording Regulatory Information
...
| MultiExcerptName | submittrialregulatory |
|---|
...
Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.
| Info |
|---|
The system will not display this section if you indicated that you do not require an XML document for ClinicalTrials.gov. |
How to Complete the Regulatory Information Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field. See the ClinicalTrials.gov Protocol Data Element Definitions for definitions for these fields.
Instructions for recording regulatory information
...
Field Label
...
Description/Instructions
...
Trial Oversight Authority Country*
...
Select the name of the country in which the oversight authority organization is located.
After you make your selection, the oversight authorities registered in the country you selected are listed in the Trial Oversight Authority Organization Name field.
...
Trial Oversight Authority Organization Name*
...
Select the name of the organization that oversees the trial from the drop-down list.
...
FDA Regulated Intervention Indicator*
...
Indicate whether the trial is regulated by the FDA by selecting Yes or No.
| Note |
|---|
You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE. |
...
Section 801 Indicator*
...
For interventional trials, indicate whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801 by selecting Yes or No.
| Note |
|---|
If you indicated that the trial is applicable under Section 801, the Delayed Posting Indicator field becomes available and defaults to No. This field is read-only. You may request a change in its value by submitting a request to the CTRO at ncictro@mail.nih.gov. |
...
Delayed Posting Indicator*
...
This indicator becomes available only when you indicate that the trial is applicable under Section 801. Only the CTRO can modify this indicator’s value:
- A No value indicates that any devices in the trial have already been approved or cleared by the US FDA, and so there is no need to delay posting of trial information information on ClinicalTrials.gov.
- A Yes value indicates that the release of trial information on ClinicalTrials.gov is being delayed until after an interventional device has been approved or cleared.
To change this indicator’s value, submit a request to the CTRO at ncictro@mail.nih.gov.
...
Data Monitoring Committee Appointed Indicator
...
Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.
| Info |
|---|
This information is required for compliance with the Public Law 110-85 of the Food and Drug Administration Amendment Act of 2007. If you are unsure about how to classify a trial, or what information to provide, contact the FDA's regulatory affairs office. |
Recording Trial-Related Documents
| Include Page | ||
|---|---|---|
|
Converting Documents to PDFs
...
Registering Abbreviated (Industrial and Other) Trials
...
| MultiExcerptName | submittrialindustry |
|---|
...
|
...
|
...
How to Register Industrial Trials
On the toolbar, click Register Trial, and select Industrial/Other.
| Tip |
|---|
To read a definition of each of the trial submission categories (study sources), click View Trial Category Definitions, or, click the Help icon ( |
...
Enter the ClinicalTrials.gov Identifier, and then click Search Studies.
The system searches for the ID you entered. If it finds a match in the CTRP, you can not import the trial.
...
If the system does not find a match in the CTRP, the trial record from ClinicalTrials.gov appears.
Click Import Trial From ClinicalTrials.gov.
| Note |
|---|
While it is possible for two users to attempt to import a trial at the exact same time, the system cannot process simultaneous imports. If you receive an error message the first time you attempt to import a trial, wait a short while, and then try again. |
...
To add your site as a participant in the trial, click Add My Site. The Add Participating Site page appears.
...
From the Participating Site list, select the organization that you want to add to this trial. Click Next. Another Add Participating Site page appears.
...
Complete the fields as per the instructions in Adding Your Site to Abbreviated Trials, and then click Save.
The system sends you an email message when the CTRO has accepted the trial for registration in the CTRP. If your trial is not Industrial, contact the CTRO at ncictro@mail.nih.gov to request categorization of the trial as either National or Externally Peer-Reviewed.
...
| Note |
|---|
The CTRP system does not import Person information from ClinicalTrials.gov. |
Printing Trial Information
...
| MultiExcerptName | submittrialprint |
|---|
...
You can print a copy of the trial details to facilitate the review and/or keep for your records. You must review the trial in order to access the print feature.
How to Print Trial Information
- Scroll to the bottom of the Register Trial page, and then click Review Trial. If necessary, provide any missing information.
- Scroll to the bottom of the Review Trial Details page, and then click Print.
Editing Trial Details
...
| MultiExcerptName | edittrialdetails |
|---|
...
You can edit the details of the trial that you are registering before you submit the trial to the CTRP. If you want to edit a registered trial that you own, follow the instructions in Updating Trials.
How to Edit Trial Details
- Scroll to the bottom of the Register Trial page, and then click Review Trial.
- Scroll to the bottom of the Review Trial Details page, and then click Edit.
The Register Trial page displays all information you have provided in editable form. - Make changes as necessary, and then click Review Trial.
- After you have reviewed your edits, click Submit.
Completing and Deleting Saved Drafts
...
| MultiExcerptName | submittrialsaveddraft |
|---|
...
During the course of registering a trial, you can save the information you have already provided as a draft , and return to it later. Once you retrieve your draft, you can complete the registration or delete the draft altogether.
How to Complete or Delete Saved Drafts
...
- To delete the record, click Delete. The draft record is deleted from the system permanently.
- or - - To complete the record, click Complete.
The Register Trial page displays all the information you provided previously. You can complete the rest of the information by following the steps in Registering a Complete Trial.
