Study start up

-

 STUDY START UP/STUDY SET UP:

eCRF(case report form):

The case report form is a printed or electronic questionnaire for collecting data from study participants and reporting it to trial sponsors. The document is created specifically for each research project in accordance with

  • the trial protocol, and

  • recommendations of the Clinical Data Acquisitions Standards Harmonization (CDASH). They are developed by Clinical Data Interchange Standards Consortium to streamline industry-wide data exchange. Say, CDASH dictates dd/mm/yy format for collecting dates. (Read our article on CDISC standards to learn more.)

Well-designed case report forms collect only data necessary for the particular study avoiding any redundancy. The fields to be filled in may include

  • demographics (age, gender),

  • basic measurements (height, weight),

  • vital signs (blood pressure, temperature, etc.) captured at various time points,

  • lab exams,

  • medical history,

  • adverse events, and

  • more, based on the research requirements.

Data managers create data entry screens and eCRF layouts in collaboration with a database programmer. The design usually goes through several review cycles before finalization.

  •  Crf pfd

  •  Compare crf pdf with protocol

  • eCRF specification-prepare

  • Explain ecrf spec to programmer

  • Draft ecrf Review,updates and changes

  • Final ecrf

  • Ecrf in EDC(electronic data management)

  • Compare ecrf spec with EDC

        EDIT CHECK DOCUMENT:  

                Edit check document

  • Edit check specification

  • Manual query and automated query

  • Dynamics 

  • Populate a query in edc

  • Provide edit check specification parallel with ecrf specification to programmer

  • Compare edit check specifications with edc

       UAT(user acceptance testing): 

  •  Role testing: testing role for team members like access

  • Screen testing

  • Structural functionality

  • Edit checks

  • Any of the data which falls out of range it should populate a query and for any thing which falls within a range that it express should not populate a query

  • LAB values-enter in UAT

  • Sponsor DM—CRO DM—LNR(lower normal range) template—Lead CRA(site)---Fill(template)---CRO CM—EDC —---manual,automated 

  •  eCRF completion guidelines

Comments

Post a Comment

Popular posts from this blog

Difference between central lab and Local Lab

-
 In the context of clinical trials, both central laboratories (central labs) and local laboratories (local labs) play essential roles in processing and analyzing biological samples. However, they differ significantly in their operations, advantages, and applications. Here’s a detailed comparison: ### Central Laboratory **Definition:** A central laboratory is a large, centralized facility that processes and analyzes samples from multiple sites participating in a clinical trial. These labs are usually equipped with advanced technology and staffed by highly trained personnel. **Key Characteristics:** - **Standardization:** Central labs offer standardized procedures and protocols, ensuring consistent and uniform testing across all samples. - **Quality Control:** They maintain stringent quality control measures, often accredited by recognized bodies (e.g., CAP, CLIA). - **Advanced Technology:** Equipped with state-of-the-art equipment and specialized assays, central labs can perform a w...
Read more

study start up

-
Image
  STUDY START UP/STUDY SET UP: eCRF(case report form): The case report form is a printed or electronic questionnaire for collecting data from study participants and reporting it to trial sponsors. The document is created specifically for each research project in accordance with the trial protocol, and recommendations of the Clinical Data Acquisitions Standards Harmonization (CDASH). They are developed by Clinical Data Interchange Standards Consortium to streamline industry-wide data exchange. Say, CDASH dictates dd/mm/yy format for collecting dates. (Read our article on CDISC standards to learn more.) Well-designed case report forms collect only data necessary for the particular study avoiding any redundancy. The fields to be filled in may include demographics (age, gender), basic measurements (height, weight), vital signs (blood pressure, temperature, etc.) captured at various time points, lab exams, medical history, adverse events, and more, based on the research requirements....
Read more

Detailed Overview of Patient Identifiers in clinical data overview

-
 Certainly! Here's a more detailed breakdown of the use of patient identifiers in clinical data review within clinical data management: ### Detailed Overview of Patient Identifiers #### Types of Patient Identifiers 1. **Direct Identifiers**    - **Name**: Directly identifies a person and is often replaced with a code in clinical trials.    - **Social Security Number**: Uniquely identifies an individual but is rarely used due to privacy concerns.    - **Contact Information**: Addresses, phone numbers, and emails are crucial for communication but are highly sensitive. 2. **Indirect Identifiers**    - **Date of Birth**: Can help identify a person, especially when combined with other information.    - **Gender**: Less specific but still helps in narrowing down identity.    - **Medical Record Numbers**: Used within healthcare systems to uniquely identify a patient but needs to be kept secure.    - **Health Plan Benefi...
Read more