Project Title: CRF Annotations for Idiopathic Pulmonary Fibrosis (IPF).

 Description:

In this Project, I have annotated every variable as domain name followed by the variable name.

e.g. DM.BRTHDTC for birth date field of demographics (DM) domain by referring the SDTM IG V3.4 for checking the variables in respective domain of SDTM.

I have followed given CDISC Rules such as:

1. All variables annotations should be in upper case.
2. Followed CDISC controlled terminologies, Code list and formats referring to SDTM IG V3.4
3. Repetitive pages (e.g. Vital signs, Labs) should refer to the original page. (e.g. “For Annotations see CRF page X”).
4. Data recorded but not submitted (e.g. Investigator’s signature or questions used for monitoring purposes “Any adverse events?”) should be annotated as “[NOTSUBMITTED]”.
5. IF same annotations used for multiple fields then 'Y'.
6. If any derivation used for some variable then it has to be written in the notes.
7. Name the annotated file “SDTM Annotations”.
8. Save CRF annotations in the format of “aCRF.xls”.

Project

1. Project Title: Development of SDTM Domain Dataset
2. Description:

   Created SDTM Demography domain dataset by using Input Datasets/Excel Files and sorted the following first 4 datasets by subject and last 2 datasets by armcd variable:

1. DM_IN.sas7bdat
2. DS.sas7bdat
3. INCO.sas7bdat
4. RAND.sas7bdat
5. RD.sas7bdat
6. TA. sas7bdat
7. Merged all input datasets by USUBJID and Created DM dataset, add the variables in the dataset and assign values as specified in the given DM_Specs.xlsx
8. Keep only the variables listed in the DM_Specs.xlsx and also retain the order of the variables as per DM_Specs.xlsx.

Project

1. Project Title: Advance Report generation 1
2. Description:
3. Generate the ‘Summary of Physical examination (Safety Analysis Set)’ report by writing independent code in SAS for 1. PE.sas7bdat and 2. ADSL.sas7bdat
4. Merged the input datasets and calculated the statistics for baseline visits and Week Day 8 visit as per RSD.
5. Used ODS statements to create RTF output.

Project

1. Project Title: Advanced Report Generation 2 (Summary of Medical / Surgical History (Enrolled Population set)
2. Description:
3. Generate the ‘Summary of Medical / Surgical History (Enrolled Population set)’ report by writing independent code in SAS For input datasets MH and adsl (Subject Level Analysis dataset).
4. Created ADMH dataset by merging input datasets and calculated the following statistics:
5. Frequency and percentages for patients with any medical history
6. Frequency and percentages classified by system organ class
7. Frequency and percentages classified by Preferred Term associated with respective System Organ Class.
8. Append all output datasets and generated report for final output dataset and Used ODS statements to create RTF output.

Project

1. Project Title: Advance Report Generation 3
2. Description:
3. Generate the ‘Summary of Dose limiting toxicities (Safety Population)’ report by writing independent code in SAS for DL, IP and ADSL input datasets.
4. Merged the input datasets.
5. Calculate count of the dose limiting toxicities.
6. Calculate percentage for the dose limiting toxicities.
7. Calculate 95 % CI using exact binomial confidence interval method.
8. Append all output datasets
9. Used ODS statements to create RTF output and generated report by using proc report for final output dataset.