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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.0 E36710-02 |
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# 3 Studies

After a product has been added to ClearTrial, a study can be created for that product. Studies are maintained from the Study List Screen. This screen allows you to create, edit, delete, and restore studies.

## 3.1 Working with Studies

Studies are created from the Study List Screen.

### 3.1.1 Study Phases

ClearTrial supports study phases II, IIa, IIb, III, IIIb, phase IV with an IND, and phase IV without an IND. ClearTrial also supports Phase I for oncology and vaccine studies, as well as Phase I studies for healthy volunteers.

The study phase is selected when a new study is created.

### 3.1.2 Creating Phase II-IV Studies

When Phase II through IV studies are created, assumptions pertaining to these phases are provided.

To create a study:

1. Navigate to the Study List Screen.

2. Click the New button to display the Create Study Screen.

3. In the Study Name field, type the study name.

4. In the Protocol field, type the protocol ID number.

   The protocol ID number identifies the protocol for this study.

5. In the Product/Compound field, select a product from the drop-down list. This list is populated with products that are created on the Product List Screen.

6. In the Phase field, select a study phase, II through IV, from the drop-down. If this is a Phase I study, see Section 3.1.3, "Creating Phase I Studies".

7. In the Sponsor field, select a study sponsor for the study.

8. In the Status field, specify the status of this study from the drop-down list.

   The status can be set to one of the following: Planning, Contract Negotiation, In Progress, Complete, or Archived.

9. In the Billing Code field, enter a billing code.

   This field allows you to specify a special billing code that may be applicable, or an abbreviation or short name for this study.

10. In the Therapeutic Area and Indication fields, select a therapeutic area from the drop down menu. To see a list of ClearTrial Therapeutic Areas and Indications, select “Therapeutic Area / Indications Mapping” from the Report menu.

    If the Therapeutic Area and Indication you need is not included, pick one that best represents the complexity of the study and substitute it with an alias name. The alias you enter will appear on all plans and reports for the study. Consult with your ClearTrial Clinical Services Manager to choose the appropriate Therapeutic Area and Indication in these situations.

11. In the Description/Notes field, enter a description that provides other users with additional information about the study.

12. Click Save.

13. To begin creating a plan for this study, click the Create Plan button at the bottom of the page to launch the Choose Template dialog box. Pick a template and click OK to begin entering assumptions for the plan.

    The other option you have for creating a plan for your study is to start from the Plan List Screen. For more information, see Working with Plans.

### 3.1.3 Creating Phase I Studies

ClearTrial supports Phase I studies for healthy volunteers and Phase I for oncology and vaccine studies.

To create a Phase I study:

1. Navigate to the Study List Screen.

2. Click the New button to display the Create Study Screen.

3. In the Study Name field, type the study name.

4. In the Protocol field, type the protocol ID number.

   The protocol ID number identifies the protocol for this study.

5. In the Product/Compound field, select a product from the drop-down list. This list is populated with products that are created on the Product List Screen.

6. In the Phase field, select either Phase I Healthy Volunteers or Phase I oncology/vaccines.

   If Phase I Healthy Volunteers is selected, the Therapeutic Area and Indication fields are set to Healthy Volunteers.

   If Phase I Oncology/vaccines is selected, you can select either "oncology" or "other" for the Therapeutic Area.

   If needed, you can select the check-box for "Substitute the names below for therapeutic area and indication" to enter an alias name for "Healthy Volunteers," "Oncology," and "Other." Consult with your ClearTrial Clinical Services Manager to choose the appropriate Therapeutic Area and Indication in these situations.

7. In the Sponsor field, select a study sponsor for the study.

8. In the Status field, specify the status of this study from the drop-down list.

   The status can be set to one of the following: Planning, Contract Negotiation, In Progress, Complete, or Archived.

9. In the Billing Code field, enter a billing code.

   This field allows you to specify a special billing code that may be applicable, or an abbreviation or short name for this study.

10. In the Description/Notes field, enter a description that provides other users with additional information about the study.

11. Click Save.

12. To begin creating a plan for this study, click the Create Plan button at the bottom of the page to launch the Choose Template dialog box. Pick a template and click OK to begin entering assumptions for the plan.

    The other option you have for creating a plan for your study is to start from the Plan List Screen. For more information, see Working with Plans.

### 3.1.4 Editing Studies

To edit a study:

1. Navigate to the Study List Screen.

2. Select a study and click the Edit button.

3. Make changes as needed and click Save.

### 3.1.5 Deleting Studies

To delete a study:

1. Navigate to the Study List Screen.

2. Select select one or more studies and click the Delete button.

### 3.1.6 Restoring Studies

To restore a study:

1. Navigate to the Study List Screen.

2. Select one or more deleted studies. If needed, adjust the filter to display deleted studies.

3. Click the Restore button.