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Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Chapter Name: Lesson 1

Introduction

Welcome to Investigator Site Responsibilities for Reporting Serious Adverse Events (SAEs) and Other Reportable Events using InForm™ elearning course. This training contains an audio narration. This training program will take approximately 60 minutes to complete. To advance to the next slide, use the next button below. Lesson Overview

Today I want to review the responsibilities of investigative sites participating in a Merck/MSD trial, for the collection and submission of data pertaining to Serious Adverse Events (SAE’s) and Other Reportable Events. The main objective of this course is to provide both the investigator and study coordinator with an understanding of their responsibilities related to the collection and reporting of event information associated with Serious Adverse Events (SAEs) & Other Reportable Events using the InForm™ system. You may find it helpful to complete your InForm™ training prior to taking this elearning course. Please note the objectives for Lesson One of this training on the screen. During the next 60 minutes I want to make sure that you have all of the information that you will need to successfully report Serious Adverse Events and Other Reportable Events using InForm™, in order that you are compliant with all applicable regulations. For the purposes of this discussion SAE will refer to Serious Adverse Event and Other Reportable Events will refer to Pregnancy and Lactation Reports and Events of Clinical Interest (ECI).

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™

Process for Reporting SAEs & Other Reportable Events–Investigator Responsibilities

When an Adverse Event or Serious Adverse Event is reported, details of the event should be recorded in your source documents. Once a subject has signed the informed consent form, Merck requires that all events meeting the criteria for non serious and Serious Adverse Events are reported in InForm™. When you are made aware that a subject has had an event that meets SAE criteria, you are required to notify Merck within 24 hours by using InForm™ to report the SAE or Other Reportable Event.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Reporting SAEs to Merck via Clinical Safety Call Center

The Clinical Safety Call Center will be contacted for SAEs that are fatal OR life threatening AND are drug or vaccine related or the drug relationship is unknown at the time of initial reporting. In addition to entering the event information into InForm™, you are also required to report the event to Merck through the “Clinical Safety Call Center” within 24 hours. It is important that the event that you are reporting meet both of these conditions to initiate a call to the Clinical Safety Call Center.

The Clinical Safety Call Center is a dedicated line for receiving calls ONLY for these events. The phone numbers for contacting your Clinical Safety call center will be located in your Global Site Trial Binder for future reference when needed. Please make note that there is one number for International use and another for Domestic use. Clinical Safety Call Center Details

The Clinical Safety Call Center is staffed by the Clinical Safety Scientist Group. The Clinical Safety call center is monitored and calls are answered in English during normal business hours (US-Eastern Standard Time). On weekends and holidays, the voice mailbox is checked twice daily for messages. Messages may be left on the dedicated Clinical Safety Call Center and should contain the following information about a Serious Adverse Event:

Product Number Protocol Number Site Number Screening or Randomization Number of the patient Adverse Event Term Serious Criteria Causality


Onset Date Investigator and Reporter Name and phone numbers

Clinical Safety Call Center Questions

This form with Clinical Safety Call Center questions will be provided to you in your Global Site Trial Binder. Please use this form as a guide to collect all of the information that will be needed when contacting the Clinical Safety Call Center to report the SAE. Let’s listen in to a study coordinator reporting a SAE to the Clinical Safety call center.

Phone conversation: Hi, today is October 21, 2008 and this is Jill Jones, Study Coordinator. My phone number is (989) 432-5121. I am calling from the US regarding MK123-Protocol Number 023. Our site number is 02 and the Primary Investigator is Dr. Remington. A patient from our site with Randomization number of 031 was reported to have experienced severe chest pain and suffered a fatal Myocardial Infarction on October 21, 2008. Dr. Remington reports that it is unknown at this time whether the Myocardial Infarction is drug related, as he is awaiting further information from the hospital. Thank you. Process for Reporting SAEs & Other Reportable Events When InFormP

TMP

is Unavailable Now I would like to talk about how you should report events to Merck if the InForm™ system is unavailable or if you are unable to access the system for any reason. It is important that you are familiar with the alternate reporting process in order to maintain regulatory compliance. In the case that InForm™ is not available, you should notify the CSS of any new or changed event information via fax using the paper AE reporting form and utilize the SAE Fax Cover Sheet when you fax the report in. Both of these documents will be located in your Global Site Trial Binder.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ If the InForm™ system is unavailable provide ONLY the required information noted on this slide on a paper AE reporting form and fax it in with an SAE Fax coversheet. Then, as soon as the InForm™ system is available or accessible to you, please enter the required information needed to complete the reporting process. This data entry process will be described to you during the next lesson in this training module.

SAE Fax Cover Sheet

This is the SAE Fax Cover Sheet which can be found in the Global Site Trial Binder. You should complete all the blank fields as indicated above.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Include this fax coversheet when faxing your paper AE reporting form to Merck. AE Report Form

This is an example of a paper AE reporting form which is found in the Global Site Trial Binder. Complete the AE Report form with only the minimal information identified – Protocol number, Site number, Screening or Randomization Number, Adverse Event Term, Serious Criteria, Causality, Onset Date, Investigator and Reporter Name.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Chapter Name: Lesson 2

Introduction

Now let’s move to Lesson 2. Lesson Overview

During this lesson you will learn about the data entry fields in the AE electronic case report forms, or eCRFs, and other related eCRFs in InFormP

TM Pand the

appropriate data to be entered into those fields. Entering the appropriate data into these fields provides the important information that the Merck Safety Department requires for Serious Adverse Event reporting.

Please note the objectives for Lesson Two of this training on the screen.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ What are the 15 Quality Attributes?

It will be evident when entering event information into InFormP

TMP, the fields that

should be populated with the attribute information because the e-CRFs were designed with these attributes in mind. Some of the attribute information will need to be entered into the text boxes to provide the complete clinical picture for the event which is required for regulatory reporting. When entering new or changed SAEs and other reportable events, such as ECI or pregnancy, into InFormP

TMP, you should also review the information for inclusion of the 15 Quality

Attributes. Your responsibility is to ensure that ALL event information is entered into InFormP

TMP.

Listed here are the 15 Quality Attributes with each attribute’s corresponding data entry location in InFormP

TMP. This document can be found in the Global Site Trial

Binder at the Investigator Site. This is a good reference to keep on hand to assist you when completing the data fields for SAE reporting in InFormP

TMP. Using the 15

Quality Attributes for reporting Serious Adverse Events and Other Reportable Events will lead to far fewer Safety Queries that will need to be addressed, thereby saving you time. During this training, you will review completing the eCFR data entry fields with emphasis on the 15 Quality Attributes.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Serious Adverse Event reporting for the subject is completed first in the AE eCRF, marking all the Serious Criteria that qualifies the event to be considered serious. Let’s begin by logging into Inform and navigating to the AE eCRF. Navigation to AE Screen

When using InFormP

TMP for a Merck trial, each site is provided with a URL or link to

the InFormP

TMP application that was setup specifically for your site. For easy access,

you may want to bookmark this link in your web browser. When you click on that link, your screen opens to the InFormP

TMP login page. Login using your site specific

user ID and password.

Navigation to AE Screen (Contd.)

After logging in, this window opens. From the menu on the left side of the screen, click on Patients.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Navigation to AE Screen (Contd.)

A listing of all patients entered into the system for your site opens. To locate your patient by Screening or Randomization number, click on the traffic light corresponding with the Visit name where data will be entered. The Adverse Event (AE) eCRF is located within each visit. For the purpose of this demonstration, you will access this module for the patient with the Randomization Number of 000100063 in Month 1 visit.


This Adverse Event screen opens. To navigate to the Adverse Event eCRF, click the Adverse Event tab at the top of the page.

As you see, there have been no entries made into the AE module for this patient. To add an Adverse Event for this patient, click on the New button at the top center of the screen.



The AE eCRF opens for this patient and the beginning of the eCRF looks like this. Some studies may have additional fields available in their AE eCRF based on the compound being researched. If there is additional data being collected for AEs and SAEs in the study that you are participating in, those fields will be noted during the Protocol Specific EDC training and in the eCRF Entry Guidelines for that study. Not all fields of this eCRF are shown on this slide.

Entry of AE/SAE Information

Let’s begin by reviewing the data fields in the AE module. After the AE or SAE data is submitted, the Adverse Event Sequence Number is generated automatically. These are system generated numbers that can be used to associate Adverse Event and Concomitant Medication records. It is necessary to associate all medications used to treat an Adverse Event. Entering Sequence Numbers from the AE or Concomitant Medication eCRFs creates the necessary links when Adverse Event Other Suspect Therapy (AESOT), or Procedures (PROC) forms are used. This will be covered in more detail later in the course.


Begin by entering the Adverse Event Term. An adverse event term is a clinical diagnosis or condition, not a list of symptoms caused by a clinical condition, unless no specific diagnosis is made. For example, enter Flu as a diagnosis, as opposed to fever, chills and achiness, which are the symptoms of Flu. Next, enter the onset date of the signs and symptoms related to the Serious Adverse Event. Remember, the onset date may be prior to the date that the serious criterion was met. For example, if an AE resulted in hospitalization 3 days after the Adverse Event was first noted, the onset date is the first day the AE was present, not the date of the hospitalization. Please see the eCRF Entry Guidelines for more detailed information related to guidelines on entry of the Adverse Event term. Entry of AE/SAE Information (Contd.)

Next, the end date, time and resolution or outcome of each AE term must be provided. This is one of the quality attributes discussed earlier. If the patient has fully recovered from the Serious Adverse Event select “Recovered.”

If a patient has recovered from the acute phase of the event with residual physical effects, which will be a new baseline for that patient, select “Recovered with Sequelae.”


An example of this is a patient who was hospitalized for a Serious Adverse Event of a cardiovascular accident and has now been discharged from rehabilitation. The patient has permanent left side paralysis. This is considered a new baseline and is “Recovered with Sequelae.” Entry of AE/SAE Information (Contd.)

Next, enter the intensity of the AE or SAE by selecting Mild, Moderate, or Severe. Entry of AE/SAE Information (Contd.)

Continuing on, information related to the action taken with the study medication is required. The action taken with study medication reflects the action taken by the Investigator OR the subject. If the Action taken with study medication is “Discontinued,” verify the Subject Disposition eCRF reflects discontinued due to the AE reported.

If the patient discontinues study medication due to multiple AE’s, the primary AE that caused the discontinuation should be the only AE that has the action taken as “Discontinued” unless a clear distinction cannot be determined. If Action Taken with study medication is “Interrupted”, verify that the Study Medication (SM) eCRF accurately reflects the interruption and reinitiating of study drug. In a study with multiple study drugs, Action Taken must be completed for each study drug. Select None for overdoses in the absence of an AE.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Entry of AE/SAE Information (Contd.)

Now, you need to assign the relationship of the AE or SAE to study drug. An adverse event’s relationship to study medication assessment Umust be made by a medically qualified principal Investigator or sub-InvestigatorU. The principle Investigator or sub-investigator making the relationship assessment must document this assessment in the subject’s chart or file. The assessment of Causality is reported according to the Investigator’s best clinical judgment. In a study with multiple study drugs, Causality must be assessed for each study medication.

If Causality is not assessed by the investigator or is reported as unknown, then causality is considered to be drug related. Serious Criteria Field

Next, complete the Serious Criteria section of the AE form. For the purposes of this demonstration, we have entered Inpatient Hospitalization as the qualifying factor. Please note the other criteria selections.

• None • Inpatient Hospitalization or prolongation of hospitalization. Please Note: If

a patient is seen in the Emergency Room, this does not qualify as inpatient hospitalization.

• Cancer, including worsening of a pre-existing cancer. • Please note: Although cancer is not an SAE criterion per ICH

Guidelines, some countries do recognize cancer as an SAE. Therefore, it is collected and reported as such. In some studies, cancer may not be considered an SAE. Please consult your clinical protocol for specific guidance on this subject.

• Immediately life threatening which places the subject, in the view of the investigator, at immediate risk of death from the event as it occurred.

• Persistent or significant disability or incapacity meaning persistent or significant disability or incapacity substantially disrupting the subjects ability to conduct normal life functions.

• Congenital anomaly or birth defect in offspring of the subject taking the product regardless of time to diagnosis.

• Overdose, whether accidental or intentional, when resulting in an AE (including lab AE’s).

• Other Important medical event which may not result in death or be life threatening or require hospitalization. However, the event may jeopardize the subject and requires medical or surgical intervention to prevent a more serious outcome, such as a life threatening event, death or hospitalization.

Please check all criteria that may apply to this Serious Adverse Event. The SAE may meet more than one of the serious criteria. If you have checked Life Threatening AND the causality has been determined to be related to study medication or the relatedness is currently unknown, report the AE to the Merck using the Clinical Safety Call Center process, as discussed in

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Lesson One. Any AEs that are fatal or life threatening however NOT drug-related do not need to be phoned into Merck Call Center.

If you have checked Overdose, this information is captured in the Study Medication Module which will be covered later in this lesson. If you have checked Death you will be directed to an additional screen to complete. SAE - Death

If the AE resulted in Death, please check that box for Serious Criteria and answer the question below: “Event reported in autopsy as cause of death?” The relationship to study medication was answered in a previously discussed field. After you complete the AE information, then the DEATH eCRF must be completed.

For the purposes of this demonstration let’s look at that window now. SAE – Death (Contd.)

If you checked Death as the Serious Criteria, you need to complete the Death eCRF with the pertinent information. The Death eCRF is located in the Final Status tab. Please enter the primary cause of death, date of the death, indicate how the investigator was notified of the death, and if an autopsy was performed.


Death Autopsy Results

If an autopsy was completed, enter any autopsy findings on the Death Autopsy Results eCRF. The Death Autopsy Results eCRF is located in the Final Status tab.

Overdose Information

Now, let’s discuss the information to consider when checking the Overdose box as Serious Criteria. Details describing the amount of study drug taken are captured on the Study Medication eCRF, which will be covered later in this module. You need to report the event in InFormP

TMP within 24 hours.

There are two scenarios for reporting an Overdose depending on whether the overdose resulted in an AE.


Overdose Information (Contd.)

Let’s discuss the first scenario for overdose. When an overdose, whether accidental or intentional, results in an AE, enter the clinical term or the abnormal test result as the AE term and check overdose for the Serious Criteria. For example: A patient unintentionally took an overdose of the study medication and experienced headaches. If headache was attributed to the overdose then the reported AE term would be headache and the criteria for SAE would be overdose. This is correct reporting of an overdose with an associated AE.

Other Serious Criteria check boxes may need to be selected based on the clinical course of events for the patient. For example: may be immediately life threatening or hospitalization. Now let’s discuss the second scenario for overdose. Overdoses that do not result in an AE are still reported in InFormP

TMP within 24 hours of investigator notification.

However, in this case, report as a Non serious adverse event. Record whether the overdose was accidental or intentional in the “AE term” field. Enter the AE Term: Accidental overdose without adverse effect or Intentional overdose without adverse effect. “Not Related” should be selected for Study Drug relationship for those study participants with an accidental overdose without an associated AE.


Finally, it is important to mark this event as an Event of Clinical Interest on the Adverse event eCRF. It is important to review the protocol for guidance as to the dosage of study medication which constitutes an overdose. Event of Clinical Interest

The next field addresses whether the AE being reported meets criteria as an Event of Clinical Interest. Please answer yes or no.

Events of Clinical interest are specifically defined in the protocol. The event must meet this definition to be considered an Event of Clinical Interest. These events are of special interest within the clinical program and are required to be entered into InFormP

TMP within 24 hours of learning of the event. You also need to complete

the bottom section of the AE eCRF for all events of clinical interest. Serious criteria may also apply. Dechallenge/Rechallenge

Please complete dechallenge and rechallenge information in the next field. Did the event improve after stopping study medication? Assess “dechallenge” regardless of the reason that drug was discontinued. If the event improved after medication was stopped - Dechallenge should be marked “Yes” If the event did not improve after medication was stopped - Dechallenge should be marked “No” Select “Not applicable” if:

o The AE resulted in death or permanent disability, o Or the AE resolved or improved despite continuation of the test drug, or if o The study is a single-dose study, or when o Reporting an overdose in the absence of an AE.

Did the event reappear or worsen after restarting the study medication? (Rechallenge)

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ If the event reappeared or worsened after study medication was restarted - Rechallenge should be marked “Yes.” If the event did not reappear or worsen after study medication was restarted - Rechallenge should be “No.” Select “not applicable” if:

o The AE resulted in death or permanent disability, o Or the AE resolved or improved despite continuation of the test drug, o Or if the study is a single-dose study, or when o Reporting an overdose in the absence of an AE.

AE Other Suspect Therapy (AEOST)

The next field addresses the relationship of the event to Other Suspect Therapy.

If the SAE is not thought to be related to drug therapy that is other than the study drug taken per protocol, check the Not Related box. If the SAE is thought to be related to drug therapy that is other than the drug taken per protocol, check the Related box. If Related is selected, the AE Other Suspect Therapy (AEOST) eCRF must be completed. This eCRF is located in the Final Status Visit. Make a note of the AE sequence number from this eCRF, since it must be entered on the AEOST eCRF to link to the specific SAE. Let’s look to see where the AEOST eCRF is accessed and how to complete that eCRF. AEOST (Contd.)

The AEOST eCRF is accessed under the Final Status Tab. Click on the AEOST tab. This tab is available to you if you entered YES - that the AE was related to Other suspect Therapy.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Click the New button located toward the top of the screen to record a new entry into this module.

AEOST (Contd.)

Begin by entering the Associated AE Sequence Number from the AE that the other suspect therapy is associated with. Next enter the Associated Suspect Therapy Sequence Number from the entry of the suspect medication in the Concomitant Medication eCRF. Complete the next three fields addressing action taken with the Other Suspect Therapy and Dechallenge and Rechallenge information, if applicable. Please note: You will need to complete this eCRF for each suspect therapy considered to be the cause of the AE.

Let’s continue on with our review of the next field in the AE eCRF. Adverse Event Information

In the next field, supporting evaluations, signs and symptoms, diagnostic tests, and/or results to corroborate each AE term reported are entered here.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Enter the onset date of signs or symptoms related to the AE. Please note: this may be prior to the date of hospitalization for an SAE. For example, the onset date of an SAE may or may not coincide with the date a serious criterion was met.

Adverse Event Information (Contd.)

In the next field on the eCRF, enter a description of the clinical course of the event. Keep in mind that all procedures related to the SAE must be entered into the Procedures eCRF. Later in the course, other eCRFs that support SAE reporting will be discussed. An example of text that may be entered into this field has been provided.


In the next field, complete the course of treatment for this event. Provided here is sample text on the information that may be captured in this text field. All concomitant medications administered for the AE also need to be entered into the Concomitant Medication eCRF. Later in the course, the Concomitant Medication eCRF and it’s relationship to completing the AE eCRF will be discussed.


This next field requests evidence supporting recovery. To complete this field, enter laboratory tests, stabilization, and resolution of symptoms to support the patient’s recovery. Also include relevant laboratory results in the Supplemental Laboratory eCRF. Provided here is sample text used in this case of a patient experiencing an SAE of Myocardial Infarction.


Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ This next field requires you to provide follow-up to the subject’s clinical course. Evidence that the SAE is a closed event may be entered if all information, such as medical records, has been received by the site and all pertinent information has been entered into InFormP

TMP. When completing this field, include in the text the

date on which follow-up information was obtained. Follow up information regarding the clinical status of the subject at last contact should be provided and the case may be closed as no additional information will be forthcoming.

Hospitalization

Hospitalization information must be entered on the Hospitalization eCRF. Enter the dates of assessment, admission, and discharge from the hospital. List all discharge diagnoses from the discharge summary. Medical judgment is needed to

determine if additional AE’s need to be recorded. eCRFs That Support SAE Reporting

Let’s look at several eCRF’s that provide data to support the Serious Adverse Event eCRF. Information in some of these eCRFs supports the 15 Quality Attributes. These supporting eCRFs are the Study Medication, Concomitant Medication, Procedures, and Supplemental Laboratory. In many cases, the data between the Adverse Event eCRF and the supporting eCRF needs to be associated by adding a Sequence number to the entry. Let us look at each supporting eCRF.


Study Medication eCRFs

There are 4 possible study medication eCRFs. A study generally uses 3 of these 4 eCRFs. Studies typically include Study Medication 01 (SM01): Date of First Dose and Study Medication 04 (SM04): Date of Last Dose, and either SM02: Study

Medication Compliance or SM03: Dose Change/Modification. SM01, SM02, and SM03 eCRFs are generally located within a study visit. SM04 is generally located in the Final Visit tab. Please refer to your study eCRF Entry Guidelines for additional information. Study Medication (SM01)–Date of First Dose

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ Let’s begin with the Study Medication 01 (SM01), Date of First Dose. This eCRF is located in the visit where the first dose of each unique study medication is administered. A portion of the eCRF is shown on this slide. Date of First Dose Information must be collected for each study medication.

Study Medication (SM02)–Study Medication Compliance

This is the Study Medication 02 (SM02), Study Medication Compliance eCRF. This eCRF captures information about all doses of study medication between the first and last doses. This eCRF may be located within study visit(s). In this example, SM02 information is located in the Month 1 Visit tab since all study medication information post Dose 1 is reviewed at the Month 1 Visit. A portion of the eCRF is shown on this slide. Study Medication Compliance information must be collected for each study medication dose.

Study Medication (SM03)–Dose Change/Modification

If a protocol did not use the SM02 eCRF to report study medication the Study Medication 03 (SM03), Change/Modification eCRF will be used.This eCRF captures information about all dose changes of study medication between the first and last

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ doses. In studies where this eCRF is used, study medication doses taken as directed by the protocol are NOT recorded. Instead only changes or modifications are recorded. If a subject missed a dose or took 2 doses, use this eCRF to document the information.

This eCRF may be located within study visit(s). A portion of the eCRF is shown on this slide. Dose Change/Modification information must be collected for each study medication. Study Medication (SM04)–Date of Last Dose

And finally, this is the Study Medication 04 (SM04), Date of Last Dose eCRF. This eCRF is located in the Final Status Visit tab. A portion of the eCRF is shown on this slide. This eCRF collects information about the last dose of study medication taken by the subject. Date of Last Dose Information must be collected for each study medication.

Concomitant Medication (CM)

Another supporting eCRF is the Concomitant Medication (CM) eCRF. Navigate to the Concomitant Medication tab, and click New to enter a new medication. The CM eCRF is located within a visit.


Concomitant Medication (CM) (Contd.)

Enter all concomitant medication taken during the Serious Adverse Event. Reporting Concomitant Medication data associated with the SAE fulfills one of the 15 Quality Attributes as noted on the screen. Be sure to complete all required fields as indicated by the asterisks. The Sequence number is automatically assigned when the eCRF is submitted. Although all fields are not shown on the slide, completion of all fields such as route of administration, daily dose and indication for use is required.

Adverse Events (AE) & Concomitant Medication (CM)

The concomitant medication used to treat an adverse event must be associated with the adverse event by marking the checkbox next to the sequence number of the appropriate adverse event in the “Associations With AE/CM: adverse events” section of the eCRF. A portion of the eCRFs (CM and AE) are shown on this slide.


Procedures (PROC)

Another eCRF that supports SAE reporting is the Procedures eCRF. The Procedures eCRF is located within a visit. To enter procedures related to an SAE report, click on the PROC tab and select New.


Procedures (PROC) (Contd.)

Only record procedures including surgeries that were related to an AE or were required for follow-up of an AE. Do not record procedures that were specified in the protocol. Enter all the appropriate AE Sequence Numbers that are related to the procedure or diagnostic. A portion of the eCRF is shown on this slide.

Supplemental Laboratory (SLAB)

Any laboratory information related to a SAE/ECI must be entered into the Supplemental Laboratory eCRF. This eCRF is located within a visit. Record each supplemental lab associated with the SAE. Navigate to the SLAB tab, and click the New button to create a new record for each supplemental lab.


Supplemental Laboratory (SLAB) (Contd.)

Complete each field for all supplemental lab entries. After all fields are completed, click submit. If needed, click New to enter another supplemental lab. The supplemental lab tests eCRF is typically used to record unspecified, non-protocol specific lab tests performed to further evaluate an adverse event or potential adverse event, or Event of Clinical Interest. Record these test results regardless if they are normal or abnormal.

Reporting Pregnancy

Now, let’s discuss the process for reporting pregnancies in InFormP

TMP. Information

is recorded on the Pregnancy eCRFs.

Course Title: Investigator Site Responsibilities For Reporting SAEs & Other Reportable Events Using InForm™ All pregnancies reported from the time of consent must be reported directly to Merck, within 24 hours of the clinical site being notified of the event, by entering the data in InFormP

TMP, on the Pregnancy eCRFs.

Only enter pregnancies on the Pregnancy eCRF. Do NOT use the AE form. Refer to protocol specific eCRF Entry Guidelines for instruction of eCRF related to pregnancy reporting.

Causality should be assessed by the investigator and recorded on the eCRF. Please see eCRF Entry Guidelines for additional information. In the case of pregnancy, C-section, and fetal loss (including spontaneous or elective abortion), blighted ovum or fetal death, the investigator should make a determination regarding relationship to study therapy (assess causality). Fetal loss (including spontaneous or elective abortion), blighted ovum or fetal death, should be entered as an SAE with causality assessed and Serious Criteria of Other Important Medical Event selected. Reporting Pregnancy (Contd.)

When reporting a pregnancy, complete the Previous and Current Pregnancy eCRF. This eCRF is located within a visit. To enter a pregnancy, click the PRG01 tab and select New.


Reporting Pregnancy (Contd.)

Next, click the PRG01 tab and complete each question. Previous pregnancy history questions are shown on this slide.


Complete each question about the current pregnancy. A portion of the current pregnancy questions are shown on this slide. The sequence number is populated after the data is submitted. In a study with multiple study drugs, relationship of pregnancy to study medication must be assessed for each study medication.



Pregnancy outcome information is recorded on the Subject Pregnancy – Fetus/Infant (PRG02) eCRF. To enter pregnancy outcome information, click the PRG02 tab and select New.


Complete each question about the pregnancy outcome. A portion of the current pregnancy questions are shown on this slide. The sequence number is populated once the data is submitted.


Please note if the infant has a congenital anomaly, then the SAE Infant (SAEI) form must be completed to report the event. If an Infant is exposed to study medication through Lactation, then a Lactation event is to be reported. Summary Points

• To summarize, let’s review a few key points related to SAE reporting. Understanding the 15 Quality attributes assists you in providing complete and pertinent information for the AE that you are reporting, thereby avoiding unnecessary and time consuming queries.

• If a query marked “24-hour Safety Query” is received, an urgent response is required within 24 hours.

• All other Safety Queries require a response within 5 days. • When InFormP

TMP is down or you are unable to access the system for any

reason, submit the required minimal SAE information required via fax, using a paper AE Report form and include an SAE fax coversheet. If you require more information on completing the paper AE Report form, please review the AER Form e-learning module which is also on myLearning.

• Please make every effort to provide the full description of the data to be entered into text fields. Reserve comments or annotations for use in providing clarification only when necessary.


• Please remember to associate the entry of concomitant medication used to treat an AE with that AE entry.

You have completed the training on capturing SAEs in InFormTM. If needed, you can view this course again at any time. Keep in mind that for your study the 15 Quality Attributes and the eCRF Entry Guidelines are very useful resources to assist you in accurate and complete reporting of SAEs in the future.

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